MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-17 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- SPNR-5SA manufactured by Abbeymoor Medical Inc..
[879753]
The physician reported that the patient presented with voiding issues. A cystoscopy was performed to determine the cause and found the spanner had been expelled. During the cystoscopy, the physician found a "deep bulb" or bulbar urethral stricture just below the level of the sphincter. The physician stated it was a very tight and difficult stricture that may have been caused by the spanner anchor, but he is unsure. The stricture was dilated and a foley catheter was passed into the patient. The spanner device was initially placed in 2008. The date of expulsion is unknown. The physician reported the patient somehow displaced the spanner on his own and that perhaps the retrieval tether was left too long. Indication for use is chronic catheter wear.
Patient Sequence No: 1, Text Type: D, B5
[8023929]
The device was not returned for evaluation. The physician reported that the stricture may have been present before spanner insertion due to patient history; however, exact cause of stricture could not be determined. The spanner ifu includes a statement that use of the device is contraindicated in patients with a history of urethral strictures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00011 |
| MDR Report Key | 1079079 |
| Report Source | 05 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-07-17 |
| Date of Event | 2008-06-01 |
| Date Mfgr Received | 2008-06-30 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2009-05-14 |
| 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 |
| Model Number | SPNR- |
| Catalog Number | SPNR-5SA |
| Lot Number | 174 |
| ID Number | 2009004-5SA |
| Device Expiration Date | 2010-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |