BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG¿

    MDR report key: 2870362 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07495
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT IT WAS INSERTED THROUGH AN INTRODUCER SHEATH. A 0.035 INCH HYDROPHILIC COATED GUIDEWIRE INSERTED THROUGH THE DEVICE. IT WAS NOTED THAT THE BALLOON MATERIAL WAS TORN CIRCUMFERENTIALLY AT APPROXIMATELY 35MM DISTAL TO THE PROXIMAL TRANSITION ZONE. THE DISTAL PORTION OF THE BALLOON IS ATTACHED TO THE DISTAL TIP. THE SINGLE LUMEN SHAFT IS SEVERELY STRETCHED AND BROKEN AT THE LAPWELD AREA. ONE OF THE RADIO OPAQUE (RO) MARKERBANDS IS MISSING OFF THE SINGLE LUMEN SHAFT. IT WAS POSSIBLE TO REMOVE THE PROXIMAL PORTION OF THE DEVICE OFF THE GUIDEWIRE; IT WAS NOT POSSIBLE TO REMOVE THE DETACHED SINGLE LUMEN SHAFT OFF THE GUIDEWIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER RELATED. THE DEVICE WAS INFLATED PAST ITS RATED BURST PRESSURE OF 20 ATM TO 24 ATM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE AND DETACHMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS BRACHIAL VEIN NEAR ANASTOMOSED PART OF SHUNT. A 6F SHEATH WS INSERTED AND A NON-BSC GUIDEWIRE WERE ADVANCED ACROSS THE LESION. THE PHYSICIAN INFLATED A 7.0 X 40MM X 40CM MUSTANG BALLOON CATHETER FOR 30 SECONDS, AT 24 ATMS THE BALLOON RUPTURED. UPON REMOVAL OF THE BALLOON CATHETER, RESISTANCE WAS ENCOUNTERED. THE BALLOON SHOULDER GOT STUCK IN THE DISTAL PART OF THE SHEATH AND FORCE WAS USED. WHEN IT WAS ATTEMPTED TO REMOVE THE DEVICE AND THE SHEATH TOGETHER THE BALLOON DETACHED AND REMAINED INSIDE THE BODY. A CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON FRAGMENT. THE SHEATH WAS REINSERTED INTO THE BODY AND A NON-BSC BALLOON CATHETER WAS USED COMPLETE THE PROCEDURE. WHEN THE DETACHED BALLOON WAS REMOVED IT WAS NOTED THAT THE RO MARKERBAND OF THE DEVICE WAS MISSING. IT IS UNKNOWN WHETHER THE MARKERBAND REMAINED INSIDE THE PATIENT. NO FURTHER 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 H74939171070440 15464563

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention