BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG PTA BALLOON DILATATION CATHETER

    MDR report key: 3024044 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-02188
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    June 27, 2012
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SHAWYER ET AL. (2012). CEPHALIC ARCH STENOSIS IN AUTOGENOUS HAEMODIALYSIS FISTULAS: TREATMENT WITH THE VIABAHN STENT-GRAFT. SPRINGER SCIENCE, CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. FROM THE INFORMATION AVAILABLE THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE COMPLAINT INFORMATION STATED THAT THE BALLOONS WERE OFTEN INFLATED ABOVE THEIR RATED BURST PRESSURES TO "OBLITERATE ANY WAISTING OF THE BALLOON". (B)(4).

    Description of Event or Problem · 1

    EVENT REPORTED VIA JOURNAL ARTICLE: "CEPHALIC ARCH STENOSIS IN AUTOGENOUS HAEMODIALYSIS FISTULAS: TREATMENT WITH THE VIABAHN STENT-GRAFT"(DR ANDREW SHAWYER ET AL). SAME CASE AS MDR ID 2134265-2013-02194, MDR ID 2134265-2013-02193 , MDR ID 2134265-2013-02191, MDR ID 2134265-2013-02192. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, VESSEL RUPTURES OCCURRED (THREE GRADE 1, ONE GRADE 2, ONE GRADE 3). THE MENTIONED VESSEL RUPTURES WERE CAUSED BY EITHER THE ULTRATHIN OR MUSTANG BALLOONS. THE ARTICLE DOES NOT SPECIFY WHICH PATIENT OR WHICH DEVICE WAS ASSOCIATED WITH WHICH GRADE RUPTURE BUT ALL 5 WERE NOTED TO REQUIRE ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127158 MUSTANG PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK696

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention