BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿ ES

    MDR report key: 2254153 · Received September 19, 2011

    Report

    Report Number
    2134265-2011-04016
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 29, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY WITH AN UNKNOWN DEGREE OF CALCIFICATION. A NON-BSC INTRODUCER SHEATH AND A NON-BSC GUIDE WIRE WERE PLACED BEFORE A 2X40MM STERLING BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. ON THE FIRST INFLATION AT 1ATM THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135204010 14408113

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO| GUIDE WIRE: CRUISE