BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3233808 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04793
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    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: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHUNT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE PERIPHERAL VEIN USING THE ANTEGRADE APPROACH. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT FOREARM VESSEL. AFTER A 0.018MM X 100CM NON-BSC GUIDEWIRE CROSSED THE LESION, A 6.0MM X 40MM X 40CM STERLING BALLOON CATHETER WAS ADVANCED. THE BALLOON WAS INFLATED FOUR TIMES: FIRST INFLATION AT 6 ATMOSPHERES; SECOND INFLATION AT 8 ATMOSPHERES; THIRD INFLATION AT 14 ATMOSPHERES BUT IT RUPTURED ON THE FOURTH INFLATION AT 14 ATMOSPHERES. SINCE IT WAS NOTED UNDER ANGIOGRAPHY THAT THE LESION WAS REASONABLY DILATED, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335476 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032604040 15406502

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE:KYOUSHA/0.018X100| INFLATION DEVICE:EVEREST/MEDTRONIC| INTRODUCER SHEATH:MOSQUITO/4FX3CM