BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2093421 · Received May 18, 2011

    Report

    Report Number
    2134265-2011-01851
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 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. 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 TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS LEFT EXTERNAL ILIAC ARTERY. THE 4.0X40MM STERLING BALLOON CATHETER WAS ADVANCED TO THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 4ATMS. THE PROCEDURE WAS COMPLETED WITH A 5.0X40MM SYMMETRY BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 H74939135404010 12878861

    Patients

    Seq Age Sex Outcome Treatment
    1 6FR TERUMO INTRODUCER SHEATH| CRUISE GUIDE WIRE