BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2860941 · Received December 6, 2012

    Report

    Report Number
    2134265-2012-07245
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE BALLOON MATERIAL WAS FULLY DEFLATED. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE FOUND NO ANOMALIES. AN ATTEMPT TO INFLATE THE BALLOON TO ITS RATED BURST PRESSURE FAILED DUE TO A PINHOLE LEAK LOCATED APPROXIMATELY 16MM DISTAL TO THE PROXIMAL TRANSITION ZONE. 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. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SHUNT IN A MODERATELY TORTUOUS VESSEL. THIS 6.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PRE-DILATION AND THE BALLOON RUPTURED AT 18ATMS UPON THE FIRST INFLATION. THE PROCEDURE WAS CONTINUED WITH ANOTHER OF THE SAME MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 SHUNT IN A MODERATELY TORTUOUS VESSEL. THIS 6.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS SELECTED FOR PRE-DILATION AND THE BALLOON RUPTURED AT 18ATMS UPON THE FIRST INFLATION. THE PROCEDURE WAS CONTINUED WITH ANOTHER OF THE SAME MUSTANG BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171060440 15535502

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: RADIFOCUS| GUIDE INTRODUCER: 5FR MOSQUITO