MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-18 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-7HA manufactured by Abbeymoor Medical Inc..
[19527479]
Physician reported when he went to remove the spanner stent, it was very tight, the retrieval string broke when he pulled on it, and the stent was then stuck in the patient. Physician removed the spanner stent via cystoscopy in a surgical suite later that same evening. He pushed the stent into the patient's bladder then used a forceps to extract the stent. Physician stated the stent was really encrusted and that he thought the encrustation on the balloon was the problem. The patient has had some episodes of uti & bleeding but declined an early change in the stent. This was the second spanner worn by the patient and had been in place for 10 weeks. The initial spanner stent was inserted after direct visual internal urethrotomy (dviu) for stricture repair post salvage cryotherapy. Patient had discomfort in the office when they tried to remove the stent and also went into retention, as the stent plugged up with debris while waiting to get him into surgery. Patient had some mild bleeding; a foley catheter was placed for overnight. The next day, the foley was removed, and another spanner was placed. Additional correspondence from physician states, patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
[19754876]
Evaluation summary: the device was returned to abbeymoor medical for evaluation. The spanner was received without the distal anchor or the retrieval suture; therefore, the location of the failure could not be determined. The spanner was heavily encrusted, especially in the proximal balloon region. The stent lumen was occluded with debris in two locations. Investigation results suggest, the likely reason for the device retrieval suture breaking at the time of removal is attributed to the heavy encrustation on the spanner proximal end which prevented the spanner from being withdrawn from the urethra in the normal fashion. Dhr review was not conducted based on results of the device inspection. Device met specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2009-00004 |
| MDR Report Key | 1565036 |
| Report Source | 05 |
| Date Received | 2009-12-18 |
| Date of Report | 2009-12-18 |
| Date of Event | 2009-11-23 |
| Date Mfgr Received | 2009-11-23 |
| Device Manufacturer Date | 2009-07-27 |
| Date Added to Maude | 2010-01-04 |
| 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 | 2009-12-18 |
| Returned To Mfg | 2009-12-01 |
| Model Number | SPNR-7HA |
| Lot Number | 217 |
| Device Expiration Date | 2012-07-01 |
| 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 | 2009-12-18 |