BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2944301 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00503
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 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 MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE 100% STENOSED TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE VESSEL HAD MODERATE TO SEVERE CALCIFICATION AND WAS MODERATELY TORTUOUS. PRE-DILATION WAS PERFORMED WITH A 3.0X40MM STERLING BALLOON. NEXT A 6.0X120MM NON-BSC STENT WAS IMPLANTED. POST DILATION WAS PERFORMED WITH A 5.0 X 60MM STERLING BALLOON INFLATED FIRST TO 10 ATMS AND THEN 2ND TO 12 ATMS ON WHICH THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 6.0X60MM STERLING BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49392 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031506010 15081821

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMINEX 6.0×120MM STENT