MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-20 for PROSTATE SEEDING NEEDLE APPLICATOR TECHNIQUE PSS1820AT manufactured by Biocompatibles.
[3458455]
This is a medical device report received on (b)(6) 2013 from a physician who reported that the trocars were dragging during a brachytherapy procedure. The reporter confirmed that during a procedure that was performed on (b)(6) it felt that the trocar was dragging inside the needle. It was described as dragging jerkily and the dragging was significant. No adverse event or patient harm was reported as a result of this device report.
Patient Sequence No: 1, Text Type: D, B5
[10683405]
Comment: a physician reported the trocars were sticking and dragging inside the needle during a prostate brachytherapy case. There was no report of harm to the patient. However, this is a reportable case because extra time was necessary to complete the procedure, which would increase the patient's potential risk of harm by being subjected to a longer period of general anesthesia than they would have if the device had functioned flawlessly. The longer a patient is under general anesthesia, the greater the potential risk. Patients, especially men in the age group that most commonly develops prostate cancer, are at risk for a cardiac, pulmonary and cns complications from anesthesia, among others, so an extension of time under anesthesia increases these risks. Therefore, this case does involve at least a potential increased risk of harm to the patient and is thus a reportable event. There is no evidence of patient harm as a result of the event evaluated in this assessment. As part of a retrospective review this complaint has bee reopened for additional investigation and analysis. This is ongoing at the time of reporting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225114-2013-00014 |
| MDR Report Key | 3136479 |
| Report Source | 06 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-05-20 |
| Date of Event | 2013-02-08 |
| Date Mfgr Received | 2013-02-08 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-07-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | WAYNE RICHARDSON, DIRECTOR |
| Manufacturer Street | 115 HURLEY ROAD BLDG 3 |
| Manufacturer City | OXFORD CT |
| Manufacturer Country | US |
| Manufacturer Phone | 2032624198 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTATE SEEDING NEEDLE APPLICATOR TECHNIQUE |
| Generic Name | SYSTEM, APPLICATOR, MANUAL |
| Product Code | IWJ |
| Date Received | 2013-05-20 |
| Model Number | PSS1820AT |
| Catalog Number | PSS1820AT |
| Lot Number | 1212081/1312859 |
| Device Expiration Date | 2017-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPATIBLES |
| Manufacturer Address | OXFORD CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-20 |