FDA Adverse Event
Malfunction
Summary report: N
ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER
MDR report key: 42914
·
Received September 30, 1996
Report
- Report Number
- 2027891-1996-00002
- Event Type
- Malfunction
- Date Received
- September 30, 1996
- Date of Event
- August 23, 1996
- Report Date
- September 27, 1996
- Manufacturer
- DEVICES FOR VASCULAR INTERVENTION, INC.
- Product Code
- MCX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING DIRECTIONAL CORONARY ATHERECTOMY (DCA) OF A CALCIFIED LESION, EIGHT PASSES WERE MADE AT 1 ATM. THE BALLOON WAS THEN INFLATED TO 2 ATMS FOR TWO MORE ADD'L PASSES. AT THAT TIME, THE CUTTER BACK INTO THE HOUSING WINDOW. THE PHYSICIAN RETRACTED THE CUTTER BACK INTO THE HOUSING WINDOW AND SAFELY REMOVED THE DEVICE FROM THE PT. THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT. THE DCA DEVICE WAS USED IN A CALCIFIED LESION WHICH ITS INSTRUCTIONS FOR USE CONTRAINDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER | CORONARY ATHERECTOMY CATHETER | MCX | DEVICES FOR VASCULAR INTERVENTION, INC. | NA | 619514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |