BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-THIN SDS BALLOON DILATATION CATHETER

    MDR report key: 1991605 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00435
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    DQY
    PMA / PMN Number
    K011889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY REMOVAL DIFFICULTIES OCCURRED. THE PHYSICIAN ADVANCED THE ULTRA-THIN (UT) BALLOON CATHETER THROUGH A NON-BSC 5FR SHEATH, INFLATED THE BALLOON ONCE TO 12 ATMS AND DEFLATED THE BALLOON. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE UT BALLOON THROUGH THE INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED AND THE SHAFT OF THE UT BALLOON CATHETER STARTED TO 'THIN' AND PULL APART. THE PHYSICIAN REMOVED THE UT BALLOON CATHETER AND NON-BSC INTRODUCER SHEATH AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-THIN SDS BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - GALWAY M001176560

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 5FR TERUMO PINNACLE