BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTOME CUTTING BALLOON

    MDR report key: 2001177 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00749
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 STENTING TREATMENT PROCEDURE, THE PROCEDURE WAS UNABLE TO BE COMPLETED. THE 90% CONCENTRIC DE NOVO LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CAROTID ARTERY. THE 2.0 X 10MM FLEXTOME MONORAIL CUTTING BALLOON CATHETER RUPTURED AT 12 ATMS DURING THE PROCEDURE. THE PHYSICIAN REMOVED THE RUPTURED BALLOON CATHETER AND THEN REMOVED THE 300 CM CHOICE PT2 GUIDE WIRE FROM THE VESSEL. THE PHYSICIAN DECIDED TO ATTEMPT TO TREAT WITH A DIFFERENT BALLOON CATHETER, HOWEVER, THE CHOICE PT2 GUIDE WIRE WAS UNABLE TO TRY TO CROSS THE LESION. THE PROCEDURE WAS NOT COMPLETED DUE TO THE LENGTH OF TIME IT WAS TAKING AND THE PATIENT'S FAMILY REQUEST. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H749RB4200100 EK5128

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 6FR GUIDING SHEATH| 300CM CHOICE PT2 GUIDE WRIE