BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3841485 · Received May 30, 2014

    Report

    Report Number
    3005099803-2014-02081
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K112994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION REVEALED THAT THE FRONT OF THE POUCH HAD A STRAIGHT CUT/HOLE DOWN THE PACKAGING NEAR THE PACKAGE LABEL. ALL POUCH SEALS WERE INTACT AND THERE WAS NO DAMAGE OBSERVED TO THE UNIT INSIDE. THE REPORTED EVENT OF HOLE IN PACKAGE WAS CONFIRMED. A PROBABLE ROOT CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THIS COMPLAINT AS IT IS MOST LIKELY THAT THE POUCH WAS DAMAGED BY HANDLING OF THE DEVICE DURING UNPACKING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT UPON RECEIPT OF A CRE WIREGUIDE WITH BILIARY BALLOON, A HOLE WAS NOTED ON THE POUCH. ACCORDING TO THE COMPLAINANT, THE PACKAGE WAS COMPROMISED AND DELIVERED DAMAGED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT UPON RECEIPT OF A CRE WIREGUIDED WITH BILIARY BALLOON, A HOLE WAS NOTED ON THE POUCH. ACCORDING TO THE COMPLAINANT, THE PACKAGE WAS COMPROMISED AND DELIVERED DAMAGED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318546 CRE? WIREGUIDED CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00558710 16809192

    Patients

    Seq Age Sex Outcome Treatment
    1