MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-07-07 for EXPRESS BILIARY LD STENT SYSTEM H74938046840750 manufactured by Boston Scientific.
[472670]
It was reported that during a right common iliac stenting treatment procedure with an express biliary ld stent system, the balloon ruptured during deployment and the stent was only partially deployed. The stent delivery balloon was removed and the post-dilatation was completed with 2 ultra thin diamond balloons. Successful stent deployment was achieved with no pt complications. The pt condition is reported as "fine. "
Patient Sequence No: 1, Text Type: D, B5
[7782641]
The device has been rec'd for analysis, but requires add'l investigation which is not complete at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000089-2006-01404 |
| MDR Report Key | 737690 |
| Report Source | 05,07 |
| Date Received | 2006-07-07 |
| Date of Report | 2006-06-08 |
| Date of Event | 2006-06-08 |
| Date Mfgr Received | 2006-06-08 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2006-07-21 |
| 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 | MARK GAYLE - MS B240 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7632550529 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPRESS BILIARY LD STENT SYSTEM |
| Generic Name | PREMOUNTED STENT SYSTEM |
| Product Code | FGF |
| Date Received | 2006-07-07 |
| Returned To Mfg | 2006-06-29 |
| Model Number | NA |
| Catalog Number | H74938046840750 |
| Lot Number | 8198801 |
| ID Number | NA |
| Device Expiration Date | 2007-11-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 725591 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | BALLYBRIT BUSINESS PARK GALWAY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-07 |