BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2982763 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01122
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; 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 FURTHER REPORTED THAT VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 8MMX80MM EPIC STENT REMAINED WELL POSITIONED AND WELL APPOSED TO THE VESSEL WALL. ONE PRE DILATION WAS PERFORMED WITH A 5MM-40MM NON BSC BALLOON CATHETER AT 16ATMS. THE 7.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS REMOVED INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS LEFT EXTERNAL ILIAC ARTERY (EIA). THE TARGET LESION WAS PREDILATED WITH A 5MMX40MM BALLOON CATHETER. A 8MMX80MM EPIC STENT WAS IMPLANTED. FOR POST DILATION, DURING THE FIRST INFLATION OF A 7.0 X 40, 135CM MUSTANG BALLOON CATHETER AT 16ATMS A BALLOON RUPTURE OCCURRED. THE MUSTANG BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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
    87099 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171070410 15626909

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE, V-18 300CM| INTRODUCER SHEATH, TERUMO 6FR DESTINATION