BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1792092 · Received August 10, 2010

    Report

    Report Number
    2134265-2010-03508
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AS A UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS THE MOST PROBABLE ROOT CAUSE CLASSIFICATION 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY A BALLOON RUPTURE AND LEAKAGE OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY. A 2X40MM STERLING ES BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 8 ATMS. AFTER 30 SECONDS, A LEAK WAS NOTED. WHEN THE DEVICE WAS REMOVED FROM THE BODY, A PINHOLE RUPTURE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135204010 13188463

    Patients

    Seq Age Sex Outcome Treatment
    1 E-CHARGE INFLATION DEVICE| PARENT 6FR MEDIKIT INTRODUCER SHEATH| X-TREME PV GUIDE WIRE