MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-05-20 for VARISTRAND AND VARILOAD, WITH SEEDLOCK NEEDLE VSKIT, VLKIT PSS1820SL3 manufactured by Biocompatibles.
[20000745]
This is a medical device report. On the (b)(6) 2012, an email was received from the medical physicist of the cancer treatment centre with a product quality question relating to prostate seeding needles. It was reported in the email that over a period of several weeks prior to the report that 3 of 5 different oncologists had found it more difficult to push the plugs out of the needles during a procedure. It had also been noted that at least 3 of the 13 patients (patient identifiers not reported) has passed seeds (both loose and stranded) post procedure; however, it was no confirmed whether this was related to the more difficult plug expulsion. Comment: in this complaint, it is noted that at least three patients apparently had seeds end up in the bladder, which they then were reported to have spontaneously passed in the urine. While this can and does occur due to seed migration itself, and is a recognized complication of the procedure, the fact that they occurred in the context of a complaint about greater difficulty using the device means that it is possible that the seeds could have inadvertently reached the bladder during the procedure. It is difficult to assess the magnitude of potential bladder injury from these events because there is no way to know how long the seeds were in fact in the bladder. We are not provided with information about how long after the procedure the seeds were passed, and even if we did, we would not know if the seeds had been in the bladder since the procedure or had just recently migrated there. Normally, a cystoscopy or other imaging procedure is done at the close of the procedure to look for seeds in the bladder, and this may well have been done, but the information packet sent to me does not comment on whether or not this was done. Regardless of how long the seeds were in the bladder, there are risks to the patient associated with unintended radiation exposure to the bladder. These risks are small, but they are not zero. Radiation injury to the bladder wall can result in prolongation of the expected post-procedure bladder-dysfunction (manifesting as difficulty voiding urine), hematuria or bladder ulceration. These events were not reported with these patients in the information i have. Scarring can result from healing of radiation-induced bladder injury that can commonly lead to future problems voiding urine. Finally, anytime there is an exposure to radiation, there is an increased risk of malignancy subsequently developing in the exposed area. Given the size of the seed, the amount of radiation, and the likelihood that the seed was not in the bladder for a prolonged period, this risk is likely very low. However, it is not zero, and an increased risk of secondary bladder malignancies after radiation therapy of prostate cancer has been documented in the medical literature, albeit mostly with external beam radiation rather than brachytherapy (although cases have been reported with brachytherapy). There is no evidence of actual patient harm as a result of the event evaluated in this assessment.
Patient Sequence No: 1, Text Type: D, B5
[20165694]
As part of a retrospective review this complaint has bee reopened for additional investigation and analysis. This is ongoing at the time of reporting. There is no evidence of actual patient harm as a result of the event evaluated in this assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225114-2013-00013 |
| MDR Report Key | 3136480 |
| Report Source | 01,06 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-05-06 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-08-23 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-07-29 |
| 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 | VARISTRAND AND VARILOAD, WITH SEEDLOCK NEEDLE |
| Generic Name | MANUAL RADIONUCLIDE APPLICATOR SYSTEM |
| Product Code | IWJ |
| Date Received | 2013-05-20 |
| Model Number | VSKIT, VLKIT |
| Catalog Number | PSS1820SL3 |
| Lot Number | R7182 (NEEDLE) |
| Device Expiration Date | 2012-08-28 |
| 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 | 1. Other | 2013-05-20 |