BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING SL BALLOON DILATATION CATHETER

    MDR report key: 2103157 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-02237
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE 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 (PTA) PROCEDURE A BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A STERLING SL BALLOON DILATATION CATHETER, STERLING SL MR 3.5 X 100 X 150 WAS ADVANCED AND INFLATED TO 6ATMS, AND A SECOND TIME TO 8 ATMS AND A BALLOON RUPTURE OCCURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT CONDITION REPORTED AS 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 H74939147351010 13832799

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING INTRODUCER: 5FR TERUMO| INFLATION DEVICE: MDT| GW: TREASURE