BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TEMPORARY PACING ELECTRODE

    MDR report key: 7210570 · Received January 22, 2018

    Report

    Report Number
    1018233-2018-00210
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Report Date
    March 23, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    LDF
    PMA / PMN Number
    K880298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RETURNED COILED UP IN A SEALED POUCH. IT WAS CONFIRMED THAT THE UNIT WAS A TEMPORARY PACING ELECTRODE (TPE) CATHETER. NO LOT NUMBER OR ITEM NUMBER WAS WRITTEN ON THE POUCH OR SHIPPING CARTON TO FURTHER IDENTIFY THE UNIT. A VISUAL INSPECTION OF THE UNIT IDENTIFIED THAT THE BALLOON WAS SEPARATED FROM THE ORIGINAL BALLOON TIE. THIS WAS CONFIRMED AS MRB WAS UNABLE TO INFLATE THE BALLOON. LOOKING AT THE UNIT UNDER MAGNIFICATION REVEALED THAT THE BALLOON SHOWED SIGNS OF MATERIAL DEGRADATION. THE DEGRADATION WAS WRAPPED AROUND THE ENTIRE BALLOON CIRCUMFERENCE. MRB DETERMINED THE ROOT CAUSE TO BE O-ZONE DEGRADATION OF THE BALLOON. THE LATEX MATERIAL IS A SENSITIVE MATERIAL THAT CAN REACT IF LEFT UNCOVERED FOR AN EXTENDED PERIOD OF TIME. IT IS PROBABLE THAT THIS DEGRADATION OCCURRED AT SOME POINT BETWEEN SHIPPING FROM GFO (GLENN FALLS) AND THE CUSTOMER'S USE. CURRENT PROCESS CONTROLS ARE SUFFICIENT TO DETECT ANY INFLATION DEFECT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. . THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE TEMPORARY PACING ELECTRODE PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. DEVICE CODE: 1310. PATIENT CODE: 2645.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE WOULD NOT INFLATE UPON PRE-TEST.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE TEMPORARY PACING ELECTRODE PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE WOULD NOT INFLATE UPON PRE-TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE WOULD NOT INFLATE UPON PRE-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54944 UNKNOWN TEMPORARY PACING ELECTRODE TEMPORARY PACING ELECTRODE LDF C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1