BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COYOTE? ES

    MDR report key: 3982790 · Received August 6, 2014

    Report

    Report Number
    2134265-2014-04614
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.; VISUAL INSPECTION SHOWED THE HUB OF THE DEVICE WAS PROTRUDING OUT THE SIDE OF THE OPENED PRODUCT POUCH 4MM. THE CARRIER TUBE (HOOP) WAS POSITIONED IN THE PRODUCT POUCH WITH THE HUB OF THE DEVICE UNDER THE TYVEK SECTION AGAINST THE EDGE OF THE VENDOR SEAL. INSPECTION OF THE REMAINDER OF THE DEVICE AND PACKAGING REVEALED NO DAMAGE OR IRREGULARITIES. NO ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING DEVICE CONTAMINATION OCCURRED. A 4MM X 40MM X 145CM COYOTE¿ ES BALLOON CATHETER WAS REMOVED FROM THE PACKAGE WHEN THE DEVICE FLIP TO THE SIDE AND WAS UNSTERILE. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING DEVICE CONTAMINATION OCCURRED. A 4MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS REMOVED FROM THE PACKAGE WHEN THE DEVICE FLIP TO THE SIDE AND WAS UNSTERILE. THE DEVICE WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459136 COYOTE? ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134404010 16920616

    Patients

    Seq Age Sex Outcome Treatment
    1