BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 3024004 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01787
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 (PTA) TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUROUS AND CALCIFIED POSTERIOR TIBIAL ARTERY. THE 1.5MM X 20MM X 143CM COYOTE ES MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. AT 14ATMS A BALLOON RUPTURE OCCURRED DURING UNSPECIFIED INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126036 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT H74939135152010 15397422

    Patients

    Seq Age Sex Outcome Treatment
    1