BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3852105 · Received June 5, 2014

    Report

    Report Number
    3005099803-2014-02108
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 13, 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

    INITIAL VISUAL INSPECTION OF THE DEVICE REVEALED NO HOLES IN THE PACKAGING; HOWEVER MANY DENTS COULD BE SEEN ON THE POUCH. THE POUCH WAS THEN INSPECTED UNDER MAGNIFICATION AND NO HOLE WAS FOUND. THE SEAL OF THE POUCH WAS FOUND TO BE INTACT. NO OTHER DEFECTS WERE NOTED. THE REPORTED DEFECT OF HOLE IN PACKAGE WAS NOT CONFIRMED; THEREFORE THIS IS NO LONGER AN MDR REPORTABLE EVENT. IN THE CASE OF THIS COMPLAINT IT IS POSSIBLE THAT THE POUCH WAS DAMAGED RESULTING IN THE DENTS DURING TRANSIT OR DURING UNPACKING FROM THE BOX IN HOSPITAL. BASED ON THE INVESTIGATION RESULTS AND AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE, AS IT IS MOST LIKELY THAT THE POUCH WAS DAMAGED BY HANDLING OF THE DEVICE DURING UNPACKING FROM THE BOX IN HOSPITAL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF HOLE IN DEVICE PACKAGING. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES INVOLVED IN THE SAME EVENT. MANUFACTURER REPORT # 3005099803-2014-02107 AND MANUFACTURER REPORT # 3005099803-2014-02108 REFERENCE THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT UPON RECEIPT OF A CRE BALLOON, THERE WERE SOME HOLES NOTED IN THE POUCH. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES INVOLVED IN THE SAME EVENT. MANUFACTURER REPORT # 3005099803-2014-02107 AND MANUFACTURER REPORT # 3005099803-2014-02108 REFERENCE THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT UPON RECEIPT OF A CRE BALLOON, THERE WERE SOME HOLES NOTED IN THE POUCH. THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329470 CRE? WIREGUIDED CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00558690 0016838457

    Patients

    Seq Age Sex Outcome Treatment
    1