BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2003504 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00452
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS WITH NO OTHER DEVICES OR ORIGINAL PACKAGING INCLUDED. THERE WAS NO BLOOD OR CONTRAST PRESENT ON THE DEVICE. EXAMINATION OF THE BALLOON REVEALED INNER SHAFT KINKS LOCATED 3CM AND 4CM FROM THE TIP. EXAMINATION OF THE MATERIAL SURROUNDING THE KINKS DID NOT REVEAL ANY EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE DEVICE WAS PREPPED AND ATTACHED TO AN INFLATION UNIT FILLED WITH WATER. THE BALLOON WAS INFLATED TO RATED BURST PRESSURE FOR FIVE MINUTES WITH NO ANOMALIES NOTED. THE BALLOON MAINTAINED CONSTANT PRESSURE WITH NO INDICATION OF ANY LEAKS. 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 PHYSICIAN WAS TREATING A 90% STENOSED LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS ARTERIOVENOUS FISTULA OF THE FOREARM. THIS 5.0 X 40/40 (4F) STERLING BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON CATHETER WAS ADVANCED TO THE LESION AND AN INITIAL INFLATION WAS MADE. ON THE SECOND INFLATION, THE BALLOON RUPTURED WHEN 14ATMS WAS REACHED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. 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 H74939032504040 13832564

    Patients

    Seq Age Sex Outcome Treatment
    1 4FR MOSQUITO INTRODUCER SHEATH