MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-17 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- SPNR-7LA manufactured by Abbeymoor Medical Inc..
[877120]
A physician reported he was unable to remove the device (during a scheduled removal) by pulling on the retrieval tether that was available at the tip of the penis. While pulling on the retrieval tether the patient experienced pain and the physician felt enough resistance to stop attempting the removal. The device was removed at a later date by cystoscopy. Upon cystoscopic removal, the physician was able to grasp the device anchor and pull it out. Upon removal the physician noted the device balloon was not fully deflated; however, the plug was out and the device was heavily encrusted. No adverse events were reported. The spanner was initially positioned in 2008, and removed on the following month. Indication for use is bph. Lot number of device was not provided.
Patient Sequence No: 1, Text Type: D, B5
[8083377]
Evaluation summary: the device was returned to abbeymoor medical for evaluation. The device was subjected to a visual examination and functional testing. Encrustation was found on the proximal portion of the stent, which partially occluded a urine entry port and the device lumen. Inflation testing was performed following device cleaning. Balloon inflation and deflation times met specification without leakage. Investigation results suggest the likely root cause for inability to remove the device was encrustation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00010 |
| MDR Report Key | 1079080 |
| Report Source | 05,06 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-07-17 |
| Date of Event | 2008-05-09 |
| Date Mfgr Received | 2008-05-14 |
| Date Added to Maude | 2009-05-11 |
| 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 EAST 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 | 2008-07-17 |
| Returned To Mfg | 2008-06-05 |
| Model Number | SPNR- |
| Catalog Number | SPNR-7LA |
| ID Number | 2009004-7LA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBEYMOOR MEDICAL INC. |
| Manufacturer Address | 501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US 56361 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-17 |