BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3951132 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04234
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 26, 2014
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE SHAFT AND BALLOON WERE MICROSCOPICALLY EXAMINED AND A 9MM LONGITUDINAL TEAR AT THE DISTAL END OF THE BALLOON WAS REVEALED. MICROSCOPICALLY EXAMINATION PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE BALLOON BURST OR REPORTED DIFFICULTY CROSSING LESION. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTY WAS ENCOUNTERED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. FOLLOWING ADVANCEMENT OF A 6FR 45CM NON-BSC INTRODUCER SHEATH AND A NON-BSC GUIDE WIRE, A 2MM X 20MM X 142CM COYOTE¿ ES BALLOON CATHETER WAS SELECTED FOR USE BUT WAS UNABLE TO CROSS. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL BALLOON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428391 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134202010 16393197

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: ASTATO/SJM| INTRODUCER SHEATH: 6FR45CM PARENT/MEDIKIT