FDA Adverse Event Malfunction Summary report: N

ROTAPRO

MDR report key: 19810577 · Received July 23, 2024

Report

Report Number: 2124215-2024-44348
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

Description of Event or Problem · 0

IT WAS REPORTED THAT THE BURR BECAME STUCK IN THE LESION. ALSO, 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.

Description of Event or Problem · 0

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
2472164	ROTAPRO	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC CORPORATION	39467-150	0033402271

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown