BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3904226 · Received July 1, 2014

    Report

    Report Number
    2134265-2014-03727
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 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

    DEVICE EVALUATED BY MFR.; THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A PINHOLE IN THE BALLOON WALL 8MM FROM THE DISTAL MARKERBAND. MICROSCOPIC EXAMINATION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE CONFIRMED BALLOON BURST. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-03728. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH ANTEGRADE APPROACH. AFTER CROSSING THE LESION WITH A NON-BSC GUIDEWIRE A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. DURING AN UNSPECIFIED INFLATION THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED THROUGH ANTEGRADE APPROACH. AFTER CROSSING THE LESION WITH A NON-BSC GUIDEWIRE A 2MM X 40MM X 144CM COYOTE¿ ES BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. DURING AN UNSPECIFIED INFLATION THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383081 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134204010 16812734

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: CRUISE 175CM AND OTHER| INTRODUCER SHEATH: PARENT 4.5 55CM