FDA Adverse Event
Injury
Summary report: N
SCIMED BOSTON SCIENTIFIC CORPORATION
MDR report key: 163518
·
Received April 15, 1998
Report
- Report Number
- 163518
- Event Type
- Injury
- Date Received
- April 15, 1998
- Manufacturer
- SCIMED LIFE SYSTEMS
- Product Code
- LOX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
POST RT. CORONARY ARTERY ATHERECTOMY (ROTABLATOR). A 3.5 X 15MM MULTILINK STENT WAS CRIMPED ON A 4.0 X 15 "NC" RANGER AND INTRODUCED IN THE RIGHT CORONARY ARTERY OSTIA. AFTER INFLATING THE BALLOON TO DEPLOY THE STENT BLOOD RETURNED IN CATHETER LUMEN IMPLICATING BALLOON HAD BURST. AFTER FLUORO GUIDANCE, IT WAS OBSERVED THE BALLOON STILL INFLATED AND WOULD NOT DISLODGE. PT. SENT TO URGENT CORONARY ARTERY BY PASS GRAFT 6 SURGERY. BALLOON EXTRACTED DURING OPEN HEART SURGERY & SENT TO PATHOLOGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCIMED BOSTON SCIENTIFIC CORPORATION | ANGIOPLASTY BALLOON- CORONARY | LOX | SCIMED LIFE SYSTEMS | 4.0 NC RANGER 15MM | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Life Threatening | VISUAL ONLY. |