BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1854118 · Received October 5, 2010

    Report

    Report Number
    2134265-2010-04464
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    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

    (B)(4): THE COMPLAINT DEVICE WAS NOT RETURNED TO BSC FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% STENOSED DENOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 4.0 X 40/80 STERLING BALLOON DILATATION CATHETER WAS SELECTED FOR PRE DILATION. THE BALLOON WAS INFLATED TO 10 ATMS FOR 40 SECONDS AND AGAIN TO 14 ATMS FOR 40 SECONDS. ON THE THIRD INFLATION TO 14 ATMS FOR 40 SECONDS, A BALLOON RUPTURE OCCURRED. THE BALLOON CATHETER WAS REMOVED AND REPLACED WITH A 4MM PERIPHERAL CUTTING BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY DEPLOYMENT OF A NON-BSC 7X4 STENT AND POST DILATION WITH A 5X4 STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032404080 13379830

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, 4F 11CM| INFLATION DEVICE, BSC ENCORE26| GUIDE WIRE, BSC V18