BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2381907 · Received December 19, 2011

    Report

    Report Number
    2134265-2011-05581
    Event Type
    Malfunction
    Date Received
    December 19, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 21, 2011
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: MAGNIFIED INSPECTION REVEALED THAT THE INNER SHAFT, OUTER SHAFT AND THE BOND THAT JOINS THE OUTER SHAFT AND THE BALLOON WERE TWISTED AND BUCKLED. THE INNER SHAFT WAS BUCKLED IN THE BALLOON BOND AREA AND BETWEEN THE MARKERBANDS. THE GUIDEWIRE WAS PROTRUDING 36CM FROM THE TIP OF THE CATHETER. THE OUTER DIAMETER OF THE WIRE WAS 0.14" (MEASURED WITH A CALIBRATED LASER MICROMETER). THE COYOTE ES DEVICE WAS PLACED IN A WARM CIRCULATING WATER BATH FOR A 24 HOUR PERIOD IN AN ATTEMPT TO SEPARATE THE DEVICES. THIS WAS UNSUCCESSFUL, THE GUIDEWIRE WAS NOT ABLE TO BE REMOVED FROM THE COYOTE ES DEVICE. THE REPORTED CATHETER-GUIDEWIRE INTERACTION WAS CONFIRMED. THERE IS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE DAMAGE. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, THE CATHETER GOT STUCK ON THE GUIDE WIRE. THE 100% STENOTIC CHRONIC TOTAL OCCLUSION LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 2MMX40MMX140CM COYOTE BALLOON. AFTER PREDILATION WAS COMPLETED THE PHYSICIAN CONNECTED AN EXTENSION GUIDE WIRE TO THE NON-BSC GUIDE WIRE AND THE CATHETER OF THE COYOTE BALLOON GOT STUCK ON THE EXTENSION GUIDE WIRE DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH A 4MMX40MMX150CM NON-BSC BALLOON. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, THE CATHETER GOT STUCK ON THE GUIDE WIRE. THE 100% STENOTIC CHRONIC TOTAL OCCLUSION LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN PREDILATED THE LESION WITH A 2MMX40MMX140CM COYOTE BALLOON. AFTER PREDILATION WAS COMPLETED THE PHYSICIAN CONNECTED AN EXTENSION GUIDE WIRE TO THE NON-BSC GUIDE WIRE AND THE CATHETER OF THE COYOTE BALLOON GOT STUCK ON THE EXTENSION GUIDE WIRE DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH A 4MMX40MMX150CM NON-BSC BALLOON. NO 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 H74939134204010 13726853

    Patients

    Seq Age Sex Outcome Treatment
    1 ENCORE26 INFLATION DEVICE| EXTENTION GUIDE WIRE| 6FR TERUMO GUIDE CATHETER| TREASURE XS GUIDE WIRE