MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-05-09 for THE SPANNER TEMPORARY PROSTATIC STENT SPNRE-9C manufactured by Abbeymoor Medical Inc..
[840488]
While soliciting product performance feedback from clinicians, the device manufacturer learned of a complete device migration into the patient's bladder. The device was initially positioned in 2007 and removed by cystoscopy at approximately two weeks later. According to the clinician an ultrasound performed immediately before removal showed the balloon and deflated. No pt info was provided. The indication for use was benign prostatic hyperplasia (bph). The spanner had been in use approximately 17 days.
Patient Sequence No: 1, Text Type: D, B5
[7992100]
The device was not returned for eval. A review of device history records (dhr) for this 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 the fda local district office, and the fda reporting systems monitoring branch in which migration events with cystoscopic removal were deemed mdr reportable. (it was initially determined that a mdr was not required for this event based on results of a clinician-based risk assessment. ) device not returned - no eval will be performed. This event occurred outside of the united states.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00002 |
| MDR Report Key | 1041248 |
| Report Source | 01,05 |
| Date Received | 2008-05-09 |
| Date of Report | 2008-05-07 |
| Date of Event | 2007-05-01 |
| Date Mfgr Received | 2007-06-05 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2009-05-15 |
| 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 | 2008-05-09 |
| Model Number | SPNRE-9C |
| Lot Number | 8 |
| ID Number | 2007011-9C |
| Device Expiration Date | 2008-09-30 |
| 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 | 2008-05-09 |