BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG?

    MDR report key: 3122302 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03307
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DURING AN ATTEMPT TO INFLATE THE BALLOON, A PINHOLE LEAK WAS IDENTIFIED. THE LEAK WAS LOCATED AT 1MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. A MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AND THE DISTAL MARKERBAND COULD NOT IDENTIFY ANY ANOMALIES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE PINHOLE LEAK. 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 BALLOON ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION BEING TREATED WAS LOCATED AT THE MODERATELY TORTUOUS AND CALCIFIED RIGHT COMMON ILIAC ARTERY. A 7.0 X 40 X 75CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. FIRST AND SECOND INFLATION WAS DONE AT 10 ATMS. UPON THIRD INFLATION, THE BALLOON RUPTURED AT 10 ATMS. THE DEVICE WAS THEN REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION BEING TREATED WAS LOCATED AT THE MODERATELY TORTUOUS AND CALCIFIED RIGHT COMMON ILIAC ARTERY. A 7.0 X 40 X 75CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. FIRST AND SECOND INFLATION WAS DONE AT 10 ATMS. UPON THIRD INFLATION, THE BALLOON RUPTURED AT 10 ATMS. THE DEVICE WAS THEN REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224245 MUSTANG? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171070470 15806377

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: TERUMO| INTRODUCER SHEATH: TERUMO| INFLATION DEVICE: MEDTRONIC