BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2132751 · Received June 17, 2011

    Report

    Report Number
    2134265-2011-02309
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 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

    (B)(4) DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED 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 TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. THE F/G STERLING OTW 6.0 X 100/135 (HYBRID) BALLOON WAS USED FOR POST-DILATATION AND RUPTURED AT 13ATMS UPON THE 3RD INFLATION AT A DURATION OF APPROXIMATELY 10 SECONDS (1ST INFLATION WAS AT 6ATMS FOR APPROXIMATELY 30 SECONDS AND THE 2ND INFLATION WAS AT 10ATMS FOR APPROXIMATELY 30 SECONDS). THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A STERLING OTW 5.0-100/4.8/135. 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 H74939032601010 14229344

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER: SHEATHLESS PV 6FR 55CM/ASAHI INTEC| GUIDEWIRE: CRUISE 014 175CM/SJM