BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIEWMATE Z CATHETER INTERFACE MODULE

    MDR report key: 11715358 · Received April 23, 2021

    Report

    Report Number
    2184149-2021-00116
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 23, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRJ
    UDI-DI
    05415067013743
    PMA / PMN Number
    K151175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VIEWMATE¿ Z CATHETER INTERFACE MODULE WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED MODULE INDICATED SIGNS OF NORMAL WEAR CONSISTENT WITH CLINICAL USE. NO PHYSICAL DAMAGE WAS DETECTED TO EITHER CONNECTOR END OR MODULE ELECTRICAL TERMINALS. FUNCTIONAL TESTING REVEALED THE ULTRASOUND CONSOLE DID NOT DETECT THE CATHETER, WHICH CONFIRMED THE FIELD REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE FIELD REPORTED ISSUE WAS ISOLATED ABNORMAL FUNCTIONALITY THE CATHETER DETECTION CIRCUITRY.

    Description of Event or Problem · 1

    DURING A CRYO ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CIM DID NOT RECOGNIZE THE CATHETERS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED INSTEAD WITH ANESTHESIA ADMINISTERED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613769 VIEWMATE Z CATHETER INTERFACE MODULE SYSTEM, SIGNAL ISOLATION DRJ ST. JUDE MEDICAL, INC. H701374 6041752 05415067013743

    Patients

    Seq Age Sex Outcome Treatment
    1