MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-20 for PROSTATE SEEDING SET APPLICATOR TECHNIQUE PSS1720AT manufactured by Biocompatibles.
[3492162]
This is a medical device report of prostate seeding needles seeming to be less sharp than usually expected. This medical device report was received from the medical physicist and additional information was provided by a physician on (b)(6) 2011 (the same day as the initial report). The reporter confirmed that three urologists had provided feedback stating that during a brachytherapy procedure, the needles appeared to be less sharp than usual and were not sharp enough to penetrate the perineal wall well. The reporter also stated that the needle deflection/trajectory seems more variable (due to deeply indented skin before the needle penetrates which alters the orientation of the needle slightly). The reporter also stated that one urologist had thought that the trocar tip was sharp but was hanging up at the front edge of the outer needle.
Patient Sequence No: 1, Text Type: D, B5
[10684146]
Company comment: a group of hcp's complained that they felt the needles were not sharp enough, resulting 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 patient 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 patient'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 patient harm as a result of the event evaluated in this assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225114-2013-00009 |
| MDR Report Key | 3136483 |
| Report Source | 05,06 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-05-20 |
| Date Mfgr Received | 2011-05-04 |
| Device Manufacturer Date | 2011-08-01 |
| 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 SET APPLICATOR TECHNIQUE |
| Generic Name | SOURCE, BRACHYTHERAPY, RADIONUCLIDE |
| Product Code | IWJ |
| Date Received | 2013-05-20 |
| Model Number | PSS1720AT |
| Catalog Number | PSS1720AT |
| Lot Number | 102993 |
| Device Expiration Date | 2015-08-01 |
| Operator | OTHER |
| 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 |