BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUSTANG¿

    MDR report key: 2834182 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-07204
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A COMPLETE BALLOON CIRCUMFERENTIAL TEAR AT 5MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. A BREAK WAS PRESENT IN THE SHAFT AT 4MM DISTAL TO THE DISTAL EDGE OF THE DISTAL MARKERBAND. AN EXAMINATION OF THE BREAK SITE FOUND THAT THE SHAFT WAS STRETCHED. THE BREAK IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. BOTH SECTIONS OF THE BREAK AND BALLOON CIRCUMFERENTIAL TEAR WERE POSITIONED ON THE RETURNED GUIDEWIRE. 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 CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED A 7.0 X 20, 40 CM MUSTANG BALLOON CATHETER TO THE TARGET LESION THEN INFLATED IT TO 20 ATMS. THE BALLOON RUPTURED AND THERE WAS A CIRCUMFERENTIAL TEAR. THE DEVICE WAS SUCCESSFULLY REMOVED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED A 7.0 X 20, 40CM MUSTANG BALLOON CATHETER TO THE TARGET LESION THEN INFLATED IT TO 20ATMS. THE BALLOON RUPTURED AND THERE WAS A CIRCUMFERENTIAL TEAR. THE DEVICE WAS SUCCESSFULLY REMOVED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUSTANG¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H74939171070240 14854499

    Patients

    Seq Age Sex Outcome Treatment
    1