BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2161392 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02684
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 14, 2011
    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). DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED STERLING ES BALLOON CATHETER REVEALED A DRIED BLOOD-LIKE SUBSTANCE IN THE BALLOON AND INFLATION LUMEN. THE BALLOON WAS IN THE DEFLATED STATE. THE BALLOON WAS TORN LONGITUDINALLY < 1 MM FROM THE DISTAL EDGE OF THE DISTAL MARKER BAND EXTENDING PROXIMALLY 6 MM. THE DISTAL END OF THE BALLOON WAS BUNCHED-UP AND THE TIP WAS DAMAGED. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE DIFFICULTY CROSSING THE LESION WAS ENCOUNTERED. THE CALCIFIED AND AVERAGELY TORTUOUS TARGET LESION WAS LOCATED IN THE 95% STENOSED RIGHT ANTERIOR TIBIAL ARTERY. A 2MM X 40MM X 145CM STERLLING ES BALLOON CATHETER WAS ADVANCED, BUT WOULD NOT CROSS THE LESION. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. RETURNED PRODUCT ANALYSIS REVEALED A TORN BALLOON.

    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 13742575

    Patients

    Seq Age Sex Outcome Treatment
    1