BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 1833870 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04100
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 27, 2010
    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): THE COMPLAINT 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

    SAME CASE AS MFR#: 2134265-2010-04101, 2134265-2010-04102. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY THREE BALLOONS RUPTURED. THE 99% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY. A STERLING ES MR 1.5MM X 20MM X 143CM RUPTURED AT FOUR ATMOSPHERES. THEN A STERLING ES MR 2MM X 20MM X 143CM BALLOON WAS USED AND RUPTURED AT SIX ATMOSPHERES. NEXT A STERLING ES MR 2.5MM X 20MM X 144CM BALLOON WAS INFLATED TO EIGHT ATMOSPHERES AND RUPTURED. 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 ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 13216783

    Patients

    Seq Age Sex Outcome Treatment
    1