BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2993401 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01725
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 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 MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED. IT WAS REPORTED THAT THE BALLOON WAS INFLATED ABOVE THE RATED BURST PRESSURE OF 12 ATMOSPHERES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ENDOVASCULAR THERAPY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS ILIAC ARTERY. AFTER CROSSING THE LESION USING A 8.0 MM X 40 MM X 135 CM STERLING BALLOON CATHETER, THE DEVICE WAS INFLATED. DURING THE UNKNOWN NUMBER OF INFLATIONS THE BALLOON RUPTURED AT 14 ATM. THE PROCEDURE WAS COMPLETED WITH A MUSTANG BALLOON CATHETER. NO COMPLICATION WERE REPORTED AND PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96798 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031804010 15220903

    Patients

    Seq Age Sex Outcome Treatment
    1