BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1951205 · Received January 6, 2011

    Report

    Report Number
    2134265-2010-05831
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    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

    (B)(6). (B)(4). 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

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 95% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. THE PHYSICIAN ADVANCED THE 8.0MM X 40MM X 80CM STERLING OTW BALLOON CATHETER ACROSS THE LESION FOR PREDILATION. THE BALLOON WAS INFLATED TO LESS THAN 14 ATMS AND RUPTURED. THE NUMBER OF INFLATIONS IS UNKNOWN. THE PHYSICIAN USED A NON-BSC DEVICE TO COMPLETE THE PROCEDURE. 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 H74939032804080 13829072

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: MEDIKIT 6FR| GUIDE WIRE: TREASURE 18| INFLATION DEVICE: ENCORE