BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3811312 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02589
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 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.: RETURNED PRODUCT CONSISTED OF COYOTE ES CATHETER WITH NO OTHER DEVICES. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN. THE DISTAL TIP WAS DAMAGED. THE DEVICE WAS PRESSURIZED WITH AN INFLATION DEVICE FILLED WITH WATER. A PINHOLE WAS IDENTIFIED IN THE BALLOON WALL ADJACENT TO THE DISTAL EDGE OF THE 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 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS UNSPECIFIED VESSEL. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS CROSSED THE LESION, HOWEVER, THE BALLOON RUPTURED AND DILATATION WAS NOT PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS UNSPECIFIED VESSEL. A 1.5MM X 20MM X 142CM COYOTE¿ ES BALLOON CATHETER WAS CROSSED THE LESION, HOWEVER, THE BALLOON RUPTURED AND DILATATION WAS NOT PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290308 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134152010 16464816

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 6F PARENT (MEDIKIT)| GUIDE WIRE: ASTATO (ST.JUDE MEDICAL)