BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING SL BALLOON DILATATION CATHETER

    MDR report key: 2040498 · Received April 6, 2011

    Report

    Report Number
    2134265-2011-01047
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K093720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT PRODUCT WAS NOT RECEIVED AT BSC FOR EVALUATION; 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 RESISTANCE AND A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED USING AN IPSILATERAL APPROACH VIA THE FEMORAL ARTERY. THE 99% STENOSED DE NOVO AND CHRONIC TOTAL OCCLUSION LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY - SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. DURING ADVANCEMENT OF A 2 X 120 X 90 STERLING SL OTW BALLOON CATHETER RESISTANCE WAS ENCOUNTERED. THE BALLOON WAS INFLATED THREE TIMES AND DURING THE THIRD INFLATION A BALLOON RUPTURE OCCURRED AT 12 ATMS. THE BALLOON CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 SL BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939148201290 13413488

    Patients

    Seq Age Sex Outcome Treatment
    1