BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE¿ ES

    MDR report key: 2961186 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00687
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 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: MAGNIFIED INSPECTION OF THE RETURNED DEVICE REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE PROXIMAL END OF THE BALLOON. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL AND 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 80% STENOSED DENOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL LOCATED BELOW THE LEFT KNEE. DURING THE FIRST ATTEMPT TO INFLATE A 2MM X 40MM X 145CM COYOTE ES BALLOON CATHETER THE BALLOON WOULD NOT INFLATE. IT WAS NOTED THAT THE BALLOON WAS FOLDED, CONTRAST MEDIA WAS LEAKING AND A BALLOON RUPTURE HAD OCCURRED DURING ADVANCEMENT. THE COYOTE ES BALLOON CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE ES BALLOON CATHETER. NO PATIENT COMPLICATION WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE 80% STENOSED DENOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL LOCATED BELOW THE LEFT KNEE. DURING THE FIRST ATTEMPT TO INFLATE A 2MM X 40MM X 145CM COYOTE ES BALLOON CATHETER THE BALLOON WOULD NOT INFLATE. IT WAS NOTED THAT THE BALLOON WAS FOLDED, CONTRAST MEDIA WAS LEAKING AND A BALLOON RUPTURE HAD OCCURRED DURING ADVANCEMENT. THE COYOTE¿ ES BALLOON CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COYOTE ES BALLOON CATHETER. NO PATIENT COMPLICATION WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65908 COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939135204010 15249641

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE, 0.014 CRUISE| INTRODUCER SHEATH, TERUMO 6FR DESTINAION