BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3122290 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03306
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    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 MANUFACTURER: THE COYOTE ES WAS RECEIVED WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. THE TIP WAS DAMAGED. THE MID-SHAFT WAS KINKED 2CM FROM THE GUIDEWIRE EXIT NOTCH. THE HYPOTUBE AND MID-SHAFT WERE KINKED AT THE BOND THAT JOINS THE HYPOTUBE AND MID-SHAFT. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A TEAR AT THE HYPOTUBE/MID-SHAFT BOND. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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 DURING THE PERCUTANEOUS PERIPHERAL INTERVENTION, BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. AFTER A NON-BSC GUIDE WIRE CROSSED THE LESION, A 4MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS DILATED, HOWEVER IT RUPTURED AT 14 ATMOSPHERES. THE DEVICE WAS EXCHANGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PERCUTANEOUS PERIPHERAL INTERVENTION, BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. AFTER A NON-BSC GUIDE WIRE CROSSED THE LESION, A 4MM X 20MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS DILATED, HOWEVER IT RUPTURED AT 14 ATMOSPHERES. THE DEVICE WAS EXCHANGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224197 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135402010 15301555

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 6FR DESTINATION| GUIDEWIRE: CRUISE, TRESUREXS