MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-30 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR SPNR-8C manufactured by Abbeymoor Medical, Inc..
[863069]
The physician reported he had a difficult time removing the spanner using the retrieval tether. During the removal procedure, the device was partially removed to the point where the device anchor protruded from the patient's meatus. The physician cut the distal anchor off and pushed the stent into the patient's bladder for later removal during a planned cystoscopic procedure. The spanner was initially positioned in 2007, and removed by cystoscopy in 2008. Indication for use in this patient is unknown.
Patient Sequence No: 1, Text Type: D, B5
[8020190]
Evaluation summary: device was returned for evaluation. The distal anchor/retrieval tether/balloon plug assembly were not returned. A microscopic evaluation of the returned device showed debris in the balloon deflation port. Further analysis suggests the debris is likely the proximal tip (epoxy dome) of the balloon plug assembly. (the balloon plug assembly is located at the end of the retrieval tether and is inserted in the balloon deflation port). Functional testing showed the balloon inflated normally and balloon drain (deflation) met specification requirements. A device history record review for the lot was performed; no concerns were raised regarding the balloon plug assembly. Likely root cause of the event appears to be the presence of debris (likely from the epoxy dome on the balloon plug assembly) in the balloon deflation port, which reduced drainage flow rate and delayed complete balloon deflation. Based on the cystoscopic procedure, the physician surmised the balloon did not fully deflate at time of initial removal and that full deflation occurred while the device was residing in the bladder. Physician stated that during the cystoscopy, he could see the balloon was deflated and grasped the device suture pulling the device out without any problem. This form fda 3500a is being submitted after the required 30-day time frame in response to recent interactions between abbeymoor, the fda local district office, and the fda reporting systems monitoring branch in which migration events with cystoscopic removal were deemed mdr reportable. (abbeymoor initially determined that an mdr was not required for this event based on results of a clinician-based risk assessment).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00006 |
| MDR Report Key | 1056494 |
| Report Source | 05 |
| Date Received | 2008-05-30 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-02-27 |
| Date Mfgr Received | 2008-02-19 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2009-05-28 |
| 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 E 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 | 2008-05-30 |
| Returned To Mfg | 2008-02-29 |
| Model Number | SPNR |
| Catalog Number | SPNR-8C |
| Lot Number | 151 |
| ID Number | 2009004-8C |
| Device Expiration Date | 2008-11-30 |
| 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 E SOO STREET PARKERS PRAIRIE MN 56361 US 56361 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-30 |