BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2994119 · Received March 8, 2013

    Report

    Report Number
    2134265-2013-01405
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT PERONEAL ARTERY. THE 3.0 X 20MM COYOTE ES OTW BALLOON WAS INFLATED AND RUPTURED ON THE 1ST INFLATION BELOW 14ATMS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A NON BSC BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100023 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134302010 14894885

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR