BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 3010805 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01592
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. VASCULAR ACCESS WAS OBTAINED WITH A 6FR NON BSC SHEATH VIA THE LEFT COMMON FEMORAL ARTERY. THE 90% STENOSED DENOVO TARGET LESION WAS LOCATED IN THE NON CALCIFIED RIGHT COMMON FEMORAL ARTERY. A 0.014INCH 175CM NON BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. A 6.0MMX40MMX135CM STERLING BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. DURING THE FIRST INFLATION AT 14ATMS A BALLOON RUPTURE OCCURRED. THE STERLING BALLOON CATHETER WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A 6MM×4CM NON BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113294 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031604010 15394392

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, TERUMO 6F DESTINATION| GUIDE WIRE, 0.014INCH 175CM CRUISE