BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 3450627 · Received November 5, 2013

    Report

    Report Number
    2134265-2013-07956
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    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 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 BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED COMMON FEMORAL ARTERY. A NON-BSC GUIDING SHEATH WAS INSERTED FROM RIGHT COMMON FEMORAL ARTERY TO THE LEFT EXTERNAL ILIAC ARTERY. A NON-BSC GUIDE WIRE WAS ADVANCED TO THE LESION. THE PHYSICIAN ATTEMPTED TO USE A 7.0MMX60MMX135CM (4F) STERLING BALLOON CATHETER HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES. THE NUMBER OF INFLATIONS IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569370 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031706010 15097962

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE:CRUISE 175CM SJM| INTRODUCER SHEATH:DESTINATION 6FR 45CM TERUMO