MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-30 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- SPNR-6C manufactured by Abbeymoor Medical Inc..
[871061]
While soliciting product performance feedback from the patient, the device manufacturer learned of a device migration event. The patient stated that he went to the emergency room in 2008 unable to urinate. The er physician inserted a catheter without removing the spanner, thereby pushing the device into the patient's bladder. The device was initially positioned on the previous month and removed via cystoscopy on twenty two days after the original date. No patient injury was reported. Indication for use is post e-beam treatment for prostate cancer.
Patient Sequence No: 1, Text Type: D, B5
[8085240]
The device was not returned for evaluation. A review of device history records (dhr) for the relevant spanner lot revealed no indication that the device used did not meet specifications. This form fda 3500a is being submitted after the required 30-day time frame in response to recent interactions between abbeymoor, the fda local district office, and the fda reporting systems monitoring branch in which migration events with cystoscopic removal were deemed mdr reportable. (abbeymoor initially determined that the mdr was not required for this event based on results of a clinician-based risk assessment).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00007 |
| MDR Report Key | 1056482 |
| Report Source | 05 |
| Date Received | 2008-05-30 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-03-25 |
| Date Mfgr Received | 2008-03-12 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2008-11-10 |
| 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 Street | 501 E SOO STREET |
| Manufacturer City | PARKERS PRAIRIE MN 56361 |
| Manufacturer Country | US |
| Manufacturer Postal | 56361 |
| Manufacturer Phone | 2183386700 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic Name | TEMPORARY PROSTATIC STENT |
| Product Code | NZC |
| Date Received | 2008-05-30 |
| Model Number | SPNR- |
| Catalog Number | SPNR-6C |
| Lot Number | 161 |
| ID Number | 2009004-6C |
| Device Expiration Date | 2008-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1267570 |
| Manufacturer | ABBEYMOOR MEDICAL INC. |
| Manufacturer Address | 501 E SOO STREET PARKERS PRAIRIE MN 56361 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-30 |