BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3936041 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04113
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 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. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A COYOTE ES BALLOON CATHETER WITH NO OTHER DEVICES. THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A 1CM LONGITUDINAL TEAR IN THE BALLOON WALL ON THE DISTAL END OF THE BALLOON. MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED 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

    SAME CASE AS MFR ID: 2134265-2014-04112 AND 2134265-2014-04115. IT WAS REPORTED THAT THE BALLOON RUPTURED. VASCULAR ACCESS WAS GAINED VIA THE COMMON FEMORAL ARTERY WITH ANTEROGRADE APPROACH. THE SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIA ARTERY NEAR THE ANKLE. THE 2.0X40MM COYOTE ES BALLOON CATHETER WAS ADVANCED AND RUPTURED AT 14ATMS. ANOTHER 2.0X40MM COYOTE ES BALLOON CATHETER WAS ADVANCED AND ALSO RUPTURED AT 14ATMS. A 2.5X40MM COYOTE ES BALLOON CATHETER WAS THEN ADVANCED AND ALSO RUPTURED AT 14ATMS. TWO OTHER NON BSC BALLOONS WERE THEN ADVANCED AND ALSO RUPTURED. ANGIOGRAPHY SHOWED THAT THE FLOW WAS RECOVERED AT THIS POINT, THEREFORE THE PROCEDURE WAS FINISHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MFR ID: 2134265-2014-04112 AND 2134265-2014-04115. IT WAS REPORTED THAT THE BALLOON RUPTURED. VASCULAR ACCESS WAS GAINED VIA THE COMMON FEMORAL ARTERY WITH ANTEROGRADE APPROACH. THE SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIA ARTERY NEAR THE ANKLE. THE 2.0X40MM COYOTE ES BALLOON CATHETER WAS ADVANCED AND RUPTURED AT 14ATMS. ANOTHER 2.0X40MM COYOTE ES BALLOON CATHETER WAS ADVANCED AND ALSO RUPTURED AT 14ATMS. A 2.5X40MM COYOTE ES BALLOON CATHETER WAS THEN ADVANCED AND ALSO RUPTURED AT 14ATMS. TWO OTHER NON BSC BALLOONS WERE THEN ADVANCED AND ALSO RUPTURED. ANGIOGRAPHY SHOWED THAT THE FLOW WAS RECOVERED AT THIS POINT, THEREFORE THE PROCEDURE WAS FINISHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413477 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135204010 16910197

    Patients

    Seq Age Sex Outcome Treatment
    1 4F INTRODUCER SHEATH| CRUISE GUIDEWIRE