MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for IODINE I125 SEEDS, IODINE (125 I) 9011 manufactured by Ge Healthcare.
[32591346]
Report #2915056-2015-00005 is a physician report from usa concerning a device malfunction with no associated adverse event. The report involves a male (age not reported) who was implanted with iodine i125 thin seeds. There were 2 needle jams and were unable to deploy during the implantation procedure for the treatment therapy of prostate cancer. Concurrent medical condition included prostate cancer. Past medical history and concomitant medications were not reported. On (b)(6) 2015, the patient underwent a brachytherapy treatment of prostate cancer with iodine i125 thin seeds (thinstrand), current activity 66. 42 mci. The lot number was provided as t15050a. Two needles loaded with 5 regularly spaced seeds planned for grid locations b 3. 5 and e 3. 5 became jammed and could not be deployed. Although the first jammed needle was replaced by a spare needle, the second needle jam was remedied by the physician manually unloading the needle and deploying loose seeds individually in 5 separate needles. Medical assessment included: the stranding material for the implanted strands was theragenics thinstrand kit was made up 106 seeds in 34 needles. Two of the needles were spare needles. The prescription dose that should encompass the entire prostate for a brachytherapy implant using iodine 125 seeds is 145 gy. This dose is achieved by placement of seeds of known activity into predetermined locations within the gland. Each one contributes to the overall dose and the creation of a dose cloud that covers the entire gland. Physicians usually order spare seeds and needles as a precaution against unforeseen circumstances such as last minute adjustments to the dose plan or other contingencies. Three needle in two implants performed on the same day, all three loaded with 5 regularly spaced seeds, were the subject of this complaint. Due to deployment of spare needles and other measures taken by the physician, both implants were completed as planned. Nonetheless the following considerations should be noted: of the seeds that made up the implant proper, 10 seeds could not be deployed, thus 10% of the dose was at risk of not being delivered. In this patient one of the needles was replaced by a spare needle but the other needle had to be physically dismantled by the physician and the seeds were individually implanted. This means that the patient had 5 additional needle insertions into the prostate gland via the perineum, thus experienced increased needle trauma to the prostate gland due to the deployment of 5 extra needles. It also means that the physician was likely exposed to additional finger dose, although details are not given regarding the method used for dismantling and reloading the individual needles. Treatment efficacy is not expected to be compromised in this case due to the use of spare needles and strategies adopted by the attending physician. At the time of reporting, the outcome was not provided. Quality assurance investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[40683255]
Review of the release documentation and paperwork for the two orders revealed that ge batch number (b)(4) (bms lot number: 14100304-1446) thinstrand suture material was used for both orders. A nonconformance report was initiated to document deterioration of this lot of material, which has affected its intended use. There had been difficulty experienced in the building of the strands leading to an increase in failures during the heating process of building tsrx orders. The two orders reported in the complaint were both processed on (b)(6) 2015 and shipped on 15-0ct-2015. The material, manufactured in oct-2014, did not contain an expiration date on its labeling provided by the supplier. Physical testing was performed on the material confirming its deteriorating condition. This has led them to believe that the condition of the material likely contributed to the jams experienced by the customer for the two orders reported in the original complaint. An incident report was provided detailing immediate actions taken with regards to this matter, including assigning a 6 month expiration period to the material from the time it is received at (b)(4). A new lot has been received that has been in process for several orders to this date without experiencing any issues of deterioration or process failures.
Patient Sequence No: 1, Text Type: N, H10
[40683257]
Report # 2915056-2015-00005 is a physician report from usa concerning a device malfunction with no associated adverse event. The report involves a male (age not reported) who was implanted with iodine i125 thin seeds. There were 2 needle jams and were unable to deploy during the implantation procedure for the treatment therapy of prostate cancer. Concurrent medical condition included prostate cancer. Past medical history and concomitant medications were not reported. On (b)(6) 2015, the patient underwent a brachytherapy treatment of prostate cancer with iodine i125 thin seeds (thinstrand), current activity 66. 42 mci. The lot number was provided as tl5050a. Two needles loaded with 5 regularly spaced seeds planned for grid locations b 3. 5 and e 3. 5 became jammed and could not be deployed. Although the first jammed needle was replaced by a spare needle, the second needle jam was remedied by the physician manually unloading the needle and deploying loose seeds individually in 5 separate needles. Medical assessment included: the stranding material for the implanted strands was theragenics' thinstrand kit was made up 106 seeds in 34 needles. Two of the needles were spare needles. The prescription dose that should encompass the entire prostate for a brachytherapy implant using iodine 125 seeds is 145 gy. This dose is achieved by placement of seeds of known activity into predetermined locations within the gland. Each one contributes to the overall dose and the creation of a dose cloud that covers the entire gland. Physicians usually order spare seeds and needles as a precaution against unforeseen circumstances such as last minute adjustments to the dose plan or other contingencies. Three needle in two implants performed on the same day, all three loaded with 5 regularly spaced seeds, were the subject of this complaint. Due to deployment of spare needles and other measures taken by the physician, both implants were completed as planned. Nonetheless the following considerations should be noted: of the seeds that made up the implant proper, 10 seeds could not be deployed, thus 10% of the dose was at risk of not being delivered. In this patient one of the needles was replaced by a spare needle but the other needle had to be physically dismantled by the physician and the seeds were individually implanted. This means that the patient had 5 additional needle insertions into the prostate gland via the perineum, thus experienced increased needle trauma to the prostate gland due to the deployment of 5 extra needles. It also means that the physician was likely exposed to additional finger dose, although details are not given regarding the method used for dismantling and reloading the individual needles. Treatment efficacy is not expected to be compromised in this case due to the use of spare needles and strategies adopted by the attending physician. At the time of reporting, the outcome was not provided. Quality assurance investigation has been initiated. Follow-up information was received on 13-nov-2015: quality assurance investigation summary: review of the release documentation and paperwork for the two orders revealed that ge batch number (b)(4) (bms lot number: 14100304-1446} thinstrand suture material was used for both orders. A nonconformance report was initiated to document deterioration of this lot of material, which has affected its intended use. There had been difficulty experienced in the building of the strands leading to an increase in failures during the heating process of building tsrx orders. The two orders reported in the complaint were both processed on (b)(6) 2015 and shipped on 15-0ct-2015. The material, manufactured in oct-2014, did not contain an expiration date on its labeling provided by the supplier. Physical testing was performed on the material confirming its deteriorating condition. This has led them to believe that the condition of the material likely contributed to the jams experienced by the customer for the two orders reported in the original complaint. Quality assurance investigation has been finalized.
Patient Sequence No: 1, Text Type: D, B5
[40745388]
Quality assurance investigation has been initiated. Follow-up information was received on november 13, 2015: quality assurance investigation summary: review of the release documentation and paperwork for the two orders revealed that ge batch number 14-erm-0753 (bms lot number: 14100304-1446) thinstrand suture material was used for both orders. A nonconformance report was initiated to document deterioration of this lot of material, which has affected its intended use. There had been difficulty experienced in the building of the strands leading to an increase in failures during the heating process of building tsrx orders. The two orders reported in the complaint were both processed on october 14, 2015 and shipped on october 15, 2015. The material, manufactured in october 2014, did not contain an expiration date on its labeling provided by the supplier. Physical testing was performed on the material confirming its deteriorating condition. This has led them to believe that the condition of the material likely contributed to the jams experienced by the customer for the two orders reported in the original complaint. Quality assurance investigation has been finalized. Follow-up information was received on november 23, 2015: additional quality assurance investigation summary: this complaint was confirmed. The braid material used to manufacture these orders ((b)(4)) was determined to be suspect and is currently under investigation per (b)(4). This lot has been quarantined and will not be used for any future tsrx orders. A new lot of braid material was sent to tgx to facilitate manufacturing for customer orders. This lot and future lots will be given a 6-month expiration from time of arrival at (b)(4) per (b)(4). Quality assurance investigation has been finalized. Review of the release documentation and paperwork for the two orders revealed that ge batch number 14-erm-0753 (bms lot number: 14100304-1446) thinstrand suture material was used for both orders. A nonconformance report was initiated to document deterioration of this lot of material, which has affected its intended use. There had been difficulty experienced in the building of the strands leading to an increase in failures during the heating process of building tsrx orders. The two orders reported in the complaint were both processed on october 14, 2015 and shipped on october 15, 2015. The material, manufactured in october 2014, did not contain an expiration date on its labeling provided by the supplier. Physical testing was performed on the material confirming its deteriorating condition. This has led them to believe that the condition of the material likely contributed to the jams experienced by the customer for the two orders reported in the original complaint. An incident report was provided detailing immediate actions taken with regards to this matter, including assigning a 6 month expiration period to the material from the time it is received at gehc. A new lot has been received that has been in process for several orders to this date without experiencing any issues of deterioration or process failures. Follow-up information was received on november 23, 2015: additional quality assurance investigation summary: this complaint was confirmed. The braid material used to manufacture these orders ((b)(4)) was determined to be suspect and is currently under investigation per (b)(4). This lot has been quarantined and will not be used for any future tsrx orders. A new lot of braid material was sent to tgx to facilitate manufacturing for customer orders. This lot and future lots will be given a 6-month expiration from time of arrival at (b)(4) per (b)(4). Quality assurance investigation has been finalized.
Patient Sequence No: 1, Text Type: N, H10
[40745389]
Report # 2915056-2015-00005 is a physician report from usa concerning a device malfunction with no associated adverse event. The report involves a male (age not reported) who was implanted with iodine i125 thin seeds. There were 2 needle jams and were unable to deploy during the implantation procedure for the treatment therapy of prostate cancer. Concurrent medical condition included prostate cancer. Past medical history and concomitant medications were not reported. On (b)(6) 2015, the patient underwent a brachytherapy treatment of prostate cancer with iodine i125 thin seeds (thinstrand), current activity 66. 42 mci. The lot number was provided as t15050a. Two needles loaded with 5 regularly spaced seeds planned for grid locations b 3. 5 and e 3. 5 became jammed and could not be deployed. Although the first jammed needle was replaced by a spare needle, the second needle jam was remedied by the physician manually unloading the needle and deploying loose seeds individually in 5 separate needles. Medical assessment included: the stranding material for the implanted strands was theragenics' thinstrand kit was made up 106 seeds in 34 needles. Two of the needles were spare needles. The prescription dose that should encompass the entire prostate for a brachytherapy implant using iodine 125 seeds is 145 gy. This dose is achieved by placement of seeds of known activity into predetermined locations within the gland. Each one contributes to the overall dose and the creation of a dose cloud that covers the entire gland. Physicians usually order spare seeds and needles as a precaution against unforeseen circumstances such as last minute adjustments to the dose plan or other contingencies. Three needle in two implants performed on the same day, all three loaded with 5 regularly spaced seeds, were the subject of this complaint. Due to deployment of spare needles and other measures taken by the physician, both implants were completed as planned. Nonetheless the following considerations should be noted: of the seeds that made up the implant proper, 10 seeds could not be deployed, thus 10% of the dose was at risk of not being delivered. In this patient one of the needles was replaced by a spare needle but the other needle had to be physically dismantled by the physician and the seeds were individually implanted. This means that the patient had 5 additional needle insertions into the prostate gland via the perineum, thus experienced increased needle trauma to the prostate gland due to the deployment of 5 extra needles. It also means that the physician was likely exposed to additional finger dose, although details are not given regarding the method used for dismantling and reloading the individual needles. Treatment efficacy is not expected to be compromised in this case due to the use of spare needles and strategies adopted by the attending physician. At the time of reporting, the outcome was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2915056-2015-00005 |
| MDR Report Key | 5250004 |
| Date Received | 2015-11-20 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-10-21 |
| Date Mfgr Received | 2015-10-22 |
| Date Added to Maude | 2015-11-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 101 CARNEGIE CENTER |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6095146000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IODINE I125 SEEDS, IODINE (125 I) |
| Generic Name | RADIONUCLIDE BRACHYTHERAPY SOURCE |
| Product Code | IWI |
| Date Received | 2015-11-20 |
| Model Number | 9011 |
| Lot Number | T15050A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | ARLINGTON HEIGHTS IL 60004 US 60004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-20 |