BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME CUTTING BALLOON

    MDR report key: 1880439 · Received October 22, 2010

    Report

    Report Number
    2134265-2010-04832
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, THE CUTTING BALLOON FROZE ON THE WIRE. VASCULAR ACCESS WAS OBTAINED THROUGH THE RADIAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. UPON ATTEMPTS TO WITHDRAW THE FLEXTOME OTW 3.50MM X 10MM CUTTING BALLOON, THE CATHETER FROZE ON THE NON BSC GUIDE WIRE. BOTH THE CUTTING BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749RB4350100 0013285161

    Patients

    Seq Age Sex Outcome Treatment
    1 6F LAUNCHER| ATHLETE GUIDE WIRE