FDA Adverse Event
Malfunction
Summary report: N
ROTAWIRE AND WIRECLIP TORQUER
MDR report key: 11369195
·
Received February 23, 2021
Report
- Report Number
- 2134265-2021-02056
- Event Type
- Malfunction
- Date Received
- February 23, 2021
- Date of Event
- February 9, 2021
- Report Date
- February 23, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MCX
- UDI-DI
- 08714729144168
- PMA / PMN Number
- P900056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BURR BECAME STUCK ON THE WIRE. A 1.25MM ROTALINK PLUS AND A ROTAWIRE AND WIRECLIP TORQUER WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WAS SEVERELY CALCIFIED AND LOCATED IN MODERATELY TORTUOUS ANATOMY. DURING WITHDRAWAL, THE BURR BECAME STUCK ON THE WIRE. THE ROTALINK PLUS COULD NOT BE PULLED BACK, SO BOTH DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265853 | ROTAWIRE AND WIRECLIP TORQUER | CATHETER, CORONARY, ATHERECTOMY | MCX | BOSTON SCIENTIFIC CORPORATION | 3560 | 0026188303 | 08714729144168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |