BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2142272 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02702
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    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 MANUFACTURER: THE 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE BRACHIAL ARTERY. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY. THE PHYSICIAN WAS USING A STERLING OVER THE WIRE 6.0 X 100/135 (HYBRID) BALLOON FOR PRE-DILATION. WHEN PHYSICIAN ATTEMPTED TO INFLATE THE DEVICE, PRESSURE DID NOT GO UP AND LEAKAGE FROM BALLOON WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032601010 14006449

    Patients

    Seq Age Sex Outcome Treatment
    1 6F 90CM DISTINATION/TERUMO INTRODUCER SHEATH| EVEREST INFLATION DEVICE| LUMINEXX 8-12-135 STENT| SJM TRESURE 0.18-175CM GUIDEWIRE