BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTOME® CUTTING BALLOON®

    MDR report key: 3113706 · Received May 15, 2013

    Report

    Report Number
    2134265-2013-03358
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 LEFT HEART CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION, THE CUTTING BALLOON CATHETER WAS DIFFICULT TO REMOVE. THE ACCESS SITE WAS THE RIGHT FEMORAL ARTERY. THE 90% STENOSED LESION IS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DISTAL ARTERY. A 06/2.50 FLEXTOME CB MR CUTTING BALLOON CATHETER WAS SELECTED TO TREAT THE LESION. DURING THE PROCEDURE, THE DEVICE WASN'T ABLE TO CROSS THE LESION AND THEY HAD TROUBLE TAKING IT OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214027 FLEXTOME® CUTTING BALLOON® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749CBM3250060 15714971

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR