BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿

    MDR report key: 3022519 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01778
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K111295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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 PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PROCEDURE TREATED THE 95% STENOSED TARGET LESION LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY. A 2.0X22MM COYOTE BALLOON CATHETER WAS ADVANCED ACROSS THE LESION, HOWEVER THE BALLOON RUPTURED AT 12ATMS. THEN A 2.0X22MM NON-BSC BALLOON CATHETER WAS ADVANCED FOR TREATMENT, BUT IT ALSO RUPTURED. NEXT A NC NON-BSC BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION AND THEN A 2.5X22MM COYOTE BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124981 COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939186202210 15590907

    Patients

    Seq Age Sex Outcome Treatment
    1