MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-03-31 for BARD BRACHYTHERAPY NEEDLE 818205 manufactured by C.r. Bard, Inc..
[1267547]
It was reported that while the urologist was inserting a brachytherapy needle in the patient, he hit the pubic arch. He started retracting the needle and said he felt a "pop". He continued removing the needle and found that the needle and broken and part of it remained in the patient. The dosimetrist checked the needle and found that in the part of the needle that was removed there was only one seed. Since the needle originally contained 5 seeds, the customer concluded that 4 seeds remained in the patient. The estimated length of the needle remaining in the patient is 3. 5 to 4. 5 cm. The procedure was aborted without any other seeds being implanted. The urologist performed a cystoscopy and a dre, both of which showed no evidence of the needle. A c-arm x-ray was performed showing the needle in the patient's prostate. The needle remaining in the patient was not immediately removed. The dosimetrist was unsure if there were plans to remove the needle. The radiation oncologist stated that they would wait for the i-125 seeds to decay for 60-120 days and then start external beam radiation to treat the patient.
Patient Sequence No: 1, Text Type: D, B5
[8438010]
A review of the device history record for the reported lot number found nothing that would cause or contribute to the reported problem. The sample was evaluated and measured 6. 047". The cannula length per specification is 7. 874"+/-0. 020". The length of the cannula of the complaint sample was found out of specification due to the broken condition of the sample. Since the broken piece of the needle remains in the patient, it is unknown the actual size of the remaining piece. A previous study found that excessive force (>6 lbs. ) was required to be applied to the cannula above what is normally experienced (1 to 2 lbs. ) in the procedure for breakage to result. An analysis of the labeling found the following: caution - needles are not intended to penetrate bone. If resistance is encountered, verify needle position. Do not push into bone; this may cause needle to bend or break. Replace needle if cannula, or point, is damaged. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2009-00014 |
| MDR Report Key | 1418603 |
| Report Source | 06 |
| Date Received | 2009-03-31 |
| Date of Report | 2009-03-27 |
| Date of Event | 2009-02-26 |
| Date Mfgr Received | 2009-02-26 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2010-02-02 |
| 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 Contact | LISA CLARK |
| Manufacturer Street | 13183 HARLAND DRIVE |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 6783424868 |
| Manufacturer G1 | BARD REYNOSA |
| Manufacturer Street | BOULEVARD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMUALIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD BRACHYTHERAPY NEEDLE |
| Product Code | IWJ |
| Date Received | 2009-03-31 |
| Returned To Mfg | 2009-03-11 |
| Model Number | NA |
| Catalog Number | 818205 |
| Lot Number | RESF0731 |
| ID Number | NA |
| Device Expiration Date | 2009-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-31 |