MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-05 for URETHRAL STENTS 800-120 manufactured by Boston Scientific.
[20237812]
It was reported that during a therapeutic stent prostatic colocation, the mesh of this stent did not move properly, so force was needed to move it causing the stent mesh to crease inside the sheath. When the stent was deployed, it occurred suddenly and partially (up to half of the stent). The rest of the stent did not deploy - it seemed blocked. Therefore, the procedure was suspended. Subsequently, a prostatic resection was performed.
Patient Sequence No: 1, Text Type: D, B5
[20550887]
This device has not been returned for evaluation. Therefore, a failure analysis is not available and we are unable to determine if the device met its specifications. Our dfu states: "the insertion of a urethral stent should not be undertaken without comprehensive knowledge of the indications, techniques and risks of the procedure. " however, we are unable to determine the relationship between the device and the cause for this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000045-2006-00015 |
| MDR Report Key | 757497 |
| Report Source | 05,06 |
| Date Received | 2006-09-05 |
| Date of Report | 2006-08-15 |
| Date of Event | 2006-08-15 |
| Date Mfgr Received | 2006-08-15 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2006-09-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | ROSE CARD |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834575 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URETHRAL STENTS |
| Generic Name | URETHRAL STENTS |
| Product Code | MER |
| Date Received | 2006-09-05 |
| Model Number | NA |
| Catalog Number | 800-120 |
| Lot Number | 8097457 |
| ID Number | NA |
| Device Expiration Date | 2006-10-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 745394 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | BALLYBRIT BUSINESS PARK GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-09-05 |