BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2211423 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03309
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. 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 DILATION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 100% OCCLUDED LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY STENOSED SUPERFICIAL FEMORAL ARTERY (SFA). A NON-BSC GUIDE WIRE AND A NON-BSC PRE-DILATION BALLOON HAD DIFFICULTY ACCESSING THE LESION IN THE CHRONICALLY TOTAL OCCLUDED SFA. AFTER A PLAIN OLD BALLOON ANGIOPLASTY, THE PHYSICIAN ADVANCED A 6.0X20/135MM STERLING BALLOON DILATION CATHETER TO THE TARGET LESION. THE BALLOON RUPTURED ON THE FIRST INFLATION. 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 BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031602010 14126761

    Patients

    Seq Age Sex Outcome Treatment
    1 NON-BSC: INTRODUCER SHEATH| NON-BSC: GUIDE WIRE