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 CE SPNR-9C manufactured by Abbeymoor Medical Inc..
[20200862]
While soliciting product performance feedback from clinicians, the device manufacturer learned of a device migration event. The pt voided fine after spanner insertion in 2007. On three days later, he was unable to void (acute urinary retention). The removal tether was not visible and a foley catheter was inserted, which pushed the spanner into the bladder. The device was removed via cystoscopy. According to the clinician, acute urinary retention may have been caused due to obstructed debris, true cause is unknown. Indication for use: pt was on waiting list for open prostatectomy surgery. The spanner had been in use for three days.
Patient Sequence No: 1, Text Type: D, B5
[20450824]
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. 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 | 3005249627-2008-00003 |
| MDR Report Key | 1041247 |
| Report Source | 01,05 |
| Date Received | 2008-05-09 |
| Date of Report | 2008-05-07 |
| Date of Event | 2007-07-21 |
| Date Mfgr Received | 2007-07-23 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2008-08-25 |
| 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 | CE SPNR-9C |
| Lot Number | 97 |
| ID Number | 2007003-9C |
| Device Expiration Date | 2009-05-31 |
| 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 | 1038574 |
| Manufacturer | ABBEYMOOR MEDICAL INC. |
| Manufacturer Address | 501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-09 |