BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 3042065 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02094
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (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 PROCEDURE, A BALLOON RUPTURE OCCURRED. USING THE RIGHT FEMORAL APPROACH, THE PROCEDURE TREATED THE 99% STENOSED TARGET LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. A 5.0X40MM STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION, HOWEVER THE BALLOON RUPTURED AT 3 ATMS ON THE FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146740 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031504010 15438688

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 6F TERUMO DESTINATION| GUIDEWIRE: 018 TREASURE