FDA Adverse Event
Injury
Summary report: N
ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER
MDR report key: 286042
·
Received July 12, 2000
Report
- Report Number
- 2024168-2000-00185
- Event Type
- Injury
- Date Received
- July 12, 2000
- Date of Event
- June 12, 2000
- Report Date
- June 13, 2000
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- MCX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING AN ATHERECTOMY AT THE LEFT ANTERIOR DESCENDING/LEFT CIRCUMFLEX BIFURCATION, THE EKG SHOWED ST ELEVATION, AND ANGIOGRAPHY DEMONSTRATED THROMBUS IN THE POSTEROLATERAL ARTERY. A STENT WAS IMPLANTED IN THE "PLA" AND THE OCCLUSION WAS REDUCED FROM 99% TO 0%. UPON REMOVAL OF THE GTO, VISUAL INSPECTION REVEALED A SMALL PINHOLE IN THE PROXIMAL BALLOON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER | CORONARY ATHERECTOMY CATHETER | MCX | GUIDANT VASCULAR INTERVENTION | NA | 0011151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | 7) IVUS ULTRA CROSS,| 6) BSX SHEATH,| 5) ACS RHV,| 2) BALANCE 190 GUIDE WIRE,| 3) JJC INFLATION DEVICE,| 4) ZUMA II JCL 3.5/4.0 GUIDING CATHETER,| 1) GRAND SLAM 300 GUIDE WIRE,| 8) NIR 3.0/25 STENT DELIVERY SYSTEM. |