BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE?

    MDR report key: 3890023 · Received June 24, 2014

    Report

    Report Number
    2134265-2014-03449
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    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

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A COYOTE BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN. THERE WAS A KINK IN THE INNER SHAFT AND BALLOON PROXIMAL OF THE PROXIMAL MARKERBAND. THE SHAFT WAS DAMAGED AT THE GUIDEWIRE EXIT NOTCH, THE DAMAGE IS CONSISTENT WITH INTERACTION WITH A GUIDEWIRE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, THE BALLOON PARTIALLY INFLATED AND WATER EMITTED FROM THE DISTAL TIP AND GUIDEWIRE EXIT NOTCH. MAGNIFIED INSPECTION REVEALED A PINHOLE IN THE INNER SHAFT 1.5MM PROXIMAL OF THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. A .014" KINETIX GUIDEWIRE WAS LOADED INTO THE TIP AND PROTRUDED THROUGH THE HOLE CONFIRMING THE HOLE TO BE CONSISTENT WITH PERFORATION OF THE SHAFT WALL WITH THE PROXIMAL END OF A GUIDEWIRE DURING CLINICAL USE OR PREPARATION FOR CLINICAL USE. THE HOLE IS CONSISTENT WITH POST-PRODUCTION DAMAGE RATHER THAN ANY MATERIAL/PROCESSING DEFECT. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS BELOW THE KNEE ARTERY. A 2.0MM X 220MM X 150CM COYOTE¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES AFTER BEING INFLATED FOR FIVE SECONDS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.0MM X 220MM COYOTE¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS BELOW THE KNEE ARTERY. A 2.0MM X 220MM X 150CM COYOTE¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES AFTER BEING INFLATED FOR FIVE SECONDS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.0MM X 220MM COYOTE¿ BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368348 COYOTE? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939185202210 16686852

    Patients

    Seq Age Sex Outcome Treatment
    1