BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2173895 · Received July 24, 2011

    Report

    Report Number
    2134265-2011-02837
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED 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

    REPORTED VIA VOLUNTARY REPORT (B)(4). IT WAS REPORTED THAT DURING A ATHERECTOMY / ANGIOPLASTY PROCEDURE A SHAFT BREAK, AND DIFFICULTY REMOVING THE CATHETER OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. PATIENT WAS ADMITTED FOR ELECTIVE PROCEDURE OF THE LEFT POPLITEAL ARTERY FOR KNOWN OCCLUSION. FOLLOWING SUCCESSFUL ATHERECTOMY AND ANGIOPLASTY OF THE HIGH GRADE LEFT POPLITEAL OCCLUSION A 3.0 X 60/135 STERLING BALLOON CATHETER BECAME COILED ON A 0.014 NON BSC GUIDE WIRE. AS THE PHYSICIAN ATTEMPTED TO REMOVE THE STERLING BALLOON CATHETER IT SEPARATED INTO TWO PIECES. BOTH SECTIONS OF THE BALLOON CATHETER WERE SUCCESSFULLY REMOVED BY REMOVING ALL ANGIOPLASTY COMPONENTS, THE STERLING BALLOON CATHETER, NON BSC GUIDE WIRE AND UNSPECIFIED SHEATH AT ONE TIME. THIS RESULTED IN A SMALL HEMATOMA AT THE LEFT FEMORAL ARTERY ACCESS SITE. THE PATIENT WAS MONITORED FOR SOME TIME AND REMAINED STABLE WITH THE ACCESS SITE CLEAN AND DRY ON DISCHARGE. THE PATIENT WAS DISCHARGED THE SAME DAY WITH INSTRUCTIONS TO FOLLOW UP WITH THE RADIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031306010 0013259845

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE, 0.014 GUIDE WIRE