MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-23 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- manufactured by Abbeymoor Medical Inc..
[1642094]
The physician called to report one of his spanner patients had gone to the emergency room (er). The physician reported that the er visit and reported renal failure were not related to the spanner device. During treatment, the er staff inserted, a foley catheter without removing the spanner not knowing the stent was in place. By inserting the foley, the spanner stent was pushed into the patient's bladder. Spanner stent was inserted on (b) (6) 2010. Indication for use was post transurethral microwave thermotherapy (tumt). Spanner was removed from the patient's bladder via cystoscopy on (b) (6). The physician passed the scope all the way in and then grabbed the retrieval string which was in the urethra to remove.
Patient Sequence No: 1, Text Type: D, B5
[8533974]
Evaluation summary: abbeymoor medical requested the device be returned for evaluation. The device was subjected to a visual examination and functional testing. Device analysis determined the spanner functioned normally and met specifications. Spanner device instructions for use have two levels of information for the patient and physician regarding this situation. Abbeymoor medical provides an emergency removal wallet card for patients that are wearing the spanner stent. Patients are instructed to provide the card to their health care providers. Under the precautions section of the patient card it states: "inserting a urinary catheter prior to removal of the spanner may result in injury to the patient. The spanner must be removed prior to catheter insertion. " physicians are prompted to alert their patients to this precaution in the physicians instructions for use as follows: "provide the patient with the emergency contact information and emergency removal card. Instruct the patient that if he requires emergency care the caregiver must be informed that the patient is wearing the spanner. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2010-00001 |
| MDR Report Key | 1667607 |
| Report Source | 05 |
| Date Received | 2010-04-23 |
| Date of Report | 2010-04-23 |
| Date of Event | 2010-03-01 |
| Date Mfgr Received | 2010-03-26 |
| Date Added to Maude | 2010-04-29 |
| 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 | MER |
| Date Received | 2010-04-23 |
| Returned To Mfg | 2010-04-19 |
| Model Number | SPNR- |
| 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 | 2010-04-23 |