MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2005-05-06 for EXPRRESS BILIARY SD PREMOUNTED STENT SYSTEM H74937911614900 manufactured by Boston Scientific.
[17825426]
It was further reported that the physician used a 5 fr cook abraham introducer sheath for vascular access, and a. 016 target stubbie guide wire to cross the lesion. A. 018 gazelle balloon was used to predilate the lesion. The pt was asymptomatic during this event.
Patient Sequence No: 1, Text Type: D, B5
[19965819]
It was reported that during a ptca / stenting treatment procedure, difficulty was encountered withdrawing the balloon of the express biliary sd stent. The lesion being treated was a mildly calcified, 90% stenotic lesion in the renal artery. The lesion was pre-dilated and the express biliary stent was advanced and deployed without difficulty. After post-diltation, it was noticed that the balloon had adhered to the stent. The balloon was inflated / deflated, and manipulated proximally and distally before it detached from the expanded stent and was withdrawn from the pt. No pt injuries or complications were reported. Patient status is reported as 'good'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000093-2005-00546 |
| MDR Report Key | 602205 |
| Report Source | 01,05,07 |
| Date Received | 2005-05-06 |
| Date of Report | 2005-04-08 |
| Date of Event | 2005-03-10 |
| Date Mfgr Received | 2005-04-08 |
| Date Added to Maude | 2005-05-16 |
| 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 | MICHELLE GUIDITH - MS B240 |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7634941194 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPRRESS BILIARY SD PREMOUNTED STENT SYSTEM |
| Generic Name | PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM |
| Product Code | FGF |
| Date Received | 2005-05-06 |
| Model Number | NA |
| Catalog Number | H74937911614900 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 592033 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | ONE SCIMED PLACE MAPLE GROVE MN 553111566 US |
| Baseline Brand Name | EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM |
| Baseline Generic Name | PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | H74937911614900 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-06 |