ROTAWIRE AND WIRECLIP TORQUER
Report
- Report Number
- 2124215-2024-44345
- Event Type
- Malfunction
- Date Received
- July 23, 2024
- Date of Event
- July 2, 2024
- Report Date
- July 29, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE WIRE. THE TARGET LESION WAS LOCATED IN THE CURVED LEFT MAIN CORONARY ARTERY (LMCA) TO RIGHT POSTERIOR ATRIOVENTRICULAR SEGMENT (PAV). A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR BECAME STUCK IN THE LESION. FURTHERMORE, AFTER BECOMING STUCK, BURR AND ROTAWIRE GOT LOCKED AND WAS NOT ABLE TO MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT THE BURR GOT STUCK WITH THE WIRE. THE TARGET LESION WAS LOCATED IN THE CURVED LEFT MAIN CORONARY ARTERY (LMCA) TO RIGHT POSTERIOR ATRIOVENTRICULAR SEGMENT (PAV). A 1.50MM ROTAPRO WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BURR BECAME STUCK IN THE LESION. FURTHERMORE, AFTER BECOMING STUCK, BURR AND ROTAWIRE GOT LOCKED AND WAS NOT ABLE TO MOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT, THE LESION WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. THE SEVERE LESION HAD A SHARP BEND AT ABOUT 90 DEGREES TO THE LEFT MAIN (LM) TO THE CIRCUMFLEX ARTERY (CX). A 1.50MM ROTAPRO AND ROTAWIRE WERE SELECTED FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2466106 | ROTAWIRE AND WIRECLIP TORQUER | CATHETER, CORONARY, ATHERECTOMY | MCX | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |