BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2834334 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-07096
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COYOTE ES CATHETER WAS RECEIVED WITH NO ORIGINAL PACKAGING. THERE WAS CONTRAST IN THE BALLOON AND INFLATION LUMEN. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE ALIGNED WITH THE MARKERBAND. THE BALLOON PRESENTED SCRATCHES IN THE BALLOON MATERIAL DISTALLY FROM THE PINHOLE. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. THE 1.5 MM X 20 MM X 143 CM COYOTE ES BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION WHEN THE BALLOON RUPTURED AT 4ATMS UPON FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. THE 1.5MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION WHEN THE BALLOON RUPTURED AT 4ATMS UPON FIRST INFLATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 14071801

    Patients

    Seq Age Sex Outcome Treatment
    1