FDA Adverse Event
Summary report: N
ROTOBLATER
MDR report key: 19014
·
Received December 7, 1994
Report
- Report Number
- MW4000617
- Date Received
- December 7, 1994
- Report Date
- December 7, 1994
- Manufacturer
- HEART TECHNOLOGY, INC.
- Product Code
- MCX
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CONSOLE HAD A LOOSE SCREW AT THE POWER SUPPLY CORD & LOOSE AIR HOSE FITTINGS BUT WAS OTHERWISE FULLY OPERATIONAL. ON BOTH DEVICES, THE BURRS HAD BEEN RETRACTED INTO THE TEFLON SHEATH & THE ADVANCE KNOBS WERE NOT FULLY RETRACTED, INDICATING THAT THE DEVICES STALLED BECAUSE THE BURRS BECAME ENTRAPPED IN THE SHEATH. IN SUMMARY, THERE IS NO EVIDENCE INDICATING ANY MALFUNCTION IN THE ROTABLATOR DEVICES USED IN THIS PROCEDURE OR THAT THESE DEVICES CAUSED OR CONTRIBUTED TO SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROTOBLATER | ATHERECTOMY CATHETER | MCX | HEART TECHNOLOGY, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |