BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3934733 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-03997
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 2014
    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. (B)(4). DEVICE EVALUATED BY MFR: 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 BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS CUTANEOUS ULNAR VEIN. A 5.0MMX20MMX40CM STERLING¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413798 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032502040 16801640

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: KYOUSHA NT| INTRODUCER SHEATH: ULTRA HIGHT FLOW 5FR| INFLATION DEVICE: ENCORE