MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-04 for PROSTATE SEEDING SET APPLICATOR TECHNIQUE PSS1720AT manufactured by Biocompatibles.
[4100854]
This is a medical device report of prostate seeding needles where the needle and trocar stylet combination was extremely reported to be dull. This medical device report was received from the medical physicist on (b)(6) 2011. The reporter confirmed that the needle and trocar stylet combination was dull. No adverse event or pt harm was reported as a result of this device report.
Patient Sequence No: 1, Text Type: D, B5
[11496124]
Company comment. An hcp complained that they felt the needles were not sharp enough. A similar earlier complaint ((b)(4)) had noted that this resulted in greater difficult penetrating the perineal skin, and "needle deflection/ trajectory seems more variable". While there is no mention of any harm occurring to any pt due to these events, the potential for harm does exist, and this is therefore a reportable event. If the needle trajectory obtained by the physician is different than the one intended by the treating physician because of problems with the device, seeds could inadvertently be placed in locations other than that intended. This raises a number of potential harm issues including inadequate treatment of the pt's prostate cancer, radiation injury to a structure where the seed was placed (or an adjacent structure), and potentially an increased risk of seed migration with its attendant complications depending on where the seed migrated to. There is no evidence of pt harm as result of the event evaluated in this assessment. As part of a retrospective review this complaint was reopened for additional investigation and analysis. The additional investigation has been concluded and this complaint is closed. See also (1) complaint summary report (2) signed medical risk assessment. A review of (b)(4) gauge needles in stock from the same lot used (102993) confirmed there were no issues or non-conformanaces associated with the production of this lot. A review of the complaint log for complaints received during the time frame of 2010 through 07/07/2013 indicated that there were no prior complaints relating to this problem, with the exception of co-complaint (b)(4) (contained within the combined complaint summary). A single definitive root cause was not identified; however a potential contributory factor was highlighted within the "process and procedures" major cause category. Inadequate needle silicone coating has been identified as a most probable root cause. A corrective and preventive action (capa) plan has been identified to address the contributory factors identified and is summarized within the complaint summary report. This complaint was specific to the applicator technique needle ((b)(4)) component of the anchorseed applicator kit (askit) sold. The applicator technique needle lot number was (102993) and the device has a 510k number of k974118. The anchorseed applicator kit lot number was 058778 and has a 510k number of k023179. The mfr risk assessment recommended corrective actions include: revision of silicone procedure (b)(4) to specify amount of needles to be siliconed at one time. Conclusion: no definitive root cause can be attributed to this complaint, however inadequate needle silicone coating has been identified as a most probable root cause. A corrective action has been assigned to revise the silicone coating procedure to specify amount of needles to be coated together or singularly. This complaint investigation has been completed and the listed outstanding actions will be transferred to the capa system for monitoring and completion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225114-2013-00018 |
| MDR Report Key | 3557967 |
| Report Source | 05,06 |
| Date Received | 2013-10-04 |
| Date of Report | 2013-10-03 |
| Date of Event | 2011-06-27 |
| Date Mfgr Received | 2011-06-27 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2014-01-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WYNE RICHARDSON, DIRECTOR |
| Manufacturer Street | 115 HURLEY ROAD BUILDING 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 SET APPLICATOR TECHNIQUE |
| Generic Name | MANUAL RADIONUCLIDE APPLICATOR SYSTEM |
| Product Code | IWJ |
| Date Received | 2013-10-04 |
| Model Number | PSS1720AT |
| Catalog Number | PSS1720AT |
| Lot Number | 102993 (NEEDLE) |
| Device Expiration Date | 2015-08-01 |
| 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 | 2013-10-04 |