BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COYOTE? ES

    MDR report key: 3872834 · Received June 13, 2014

    Report

    Report Number
    2134265-2014-03268
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Adverse Event
    Yes
    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). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER WITH NO PACKAGING OR OTHER DEVICES. THE DISTAL END OF THE CATHETER WAS RETURNED; A 24.5 CM LONG SECTION INCLUDING THE OUTER, INNER, BALLOON AND DISTAL TIP. THE PROXIMAL END OF THE CATHETER, INCLUDING THE HUB, WAS DISPOSED OF BY THE PHYSICIAN. THE CATHETER WAS INSPECTED TACTUALLY AND UNDER MAGNIFICATION. THERE WAS BLOOD IN THE INFLATION LUMEN AND IN THE BALLOON. SHAFT DAMAGE INCLUDING KINKS, BUCKLING AND FLATTENED SECTIONS, WAS NOTED ALONG THE ENTIRE LENGTH OF THE RETURNED PORTION. THE INNER WAS ALSO TWISTED 16.5CM AND 11CM FROM THE DISTAL TIP. THE STRETCHED AND TWISTED APPEARANCE OF THE SHAFT AT THE BREAK SUGGESTS THAT THE DAMAGE MAY HAVE BEEN RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING 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 PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT BRACHIAL ARTERY AND RIGHT POPLITEAL ARTERY WITH BIDIRECTIONAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS RIGHT COMMON ILIAC ARTERY TO COMMON FEMORAL ARTERY. A 0.014X175 NON BSC GUIDE WIRE WAS ADVANCED FROM THE RIGHT BRACHIAL ARTERY AND CROSSED THE LESION. THEN, A 1.5MM X 20MM X 143CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. DURING MANIPULATION OF THE DEVICE, THE SHAFT WAS DETACHED INSIDE THE PATIENT. THE DETACHED SHAFT WAS RETRIEVED WITH A SNARE. THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCING AND WITHDRAWAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING A 2X2 COYOTE¿ ES BALLOON CATHETER AND AN UNSPECIFIED STENT WAS DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349792 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135152010 16726132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFLATION DEVICE:ENCORE/BSJ| GUIDEWIRE:TRESUREXS/0.014X175/SJM| INTRODUCER SHEATH:DESTINATION/6FRX90CM/TERUMO