BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1943737 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05691
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) 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 (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED, DE NOVO LESION WAS LOCATED IN A MILDLY CALCIFIED AND MODERATELY TORTUOUS BRACHIAL VEIN. THE PHYSICIAN ADVANCED THE 5.0MM X 100MM STERLING BALLOON CATHETER AND SUCCESSFULLY INFLATED THE BALLOON TO 8ATMS. UPON THE SECOND INFLATION TO 8ATMS THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 H74939032501080 12812704

    Patients

    Seq Age Sex Outcome Treatment
    1 RADIOFOCUS 0.018 GUIDE WIRE| 4F ZEON INTRODUCER SHEATH| NIPURO INFLATION DEVICE