BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE, STAINLES

    MDR report key: 11777747 · Received May 5, 2021

    Report

    Report Number
    1018233-2021-02588
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 12, 2021
    Report Date
    November 15, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    LDF
    PMA / PMN Number
    K800298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE DID NOT FAIL TO MEET RELEVANT SPECIFICATIONS. THE PRODUCT CAN BE USING FOR DIAGNOSTIC AND TREATMENT PURPOSES, AND WAS NOT SPECIFIED IN THE REPORTED EVENT WHAT PURPOSE IT WAS USED FOR. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. AS THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. H11: SECTION A THROUGH F - 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARD TEMPERATURE PACER BALLOON WOULD NOT INFLATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARD TEMPERATURE PACER BALLOON WOULD NOT INFLATE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BARD TEMPERATURE PACER BALLOON WOULD NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674193 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE, STAINLES TEMPORARY PACING ELECTRODE CATHETER LDF C.R. BARD, INC. (COVINGTON) -1018233 UNK
    674201 BALLOON BIPOLAR TEMPORARY PACING ELECTRODE CATHETER, RIGHT HEART CURVE, STAINLES TEMPORARY PACING ELECTRODE CATHETER LDF C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other