BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRY¿ ELECTROPHYSIOLOGY CATHETER, INQUIRY¿ AFOCUS II¿ EB CATHETER, 110 CM LEN

    MDR report key: 7121761 · Received December 15, 2017

    Report

    Report Number
    2030404-2017-00055
    Event Type
    Injury
    Date Received
    December 15, 2017
    Report Date
    December 15, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    PMA / PMN Number
    K042775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A DETACHED TIP ELECTRODE COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE HEARTRHYTHM CASE REPORTS IN VOLUME 3, ISSUE 11, NOVEMBER 2017: "A (B)(6) MAN WITH PAROXYSMAL AF UNDERWENT ISOLATION OF ALL 4 PVS USING A CRYOABLATION BALLOON. ALL 4 PVS WERE SUCCESSFULLY ISOLATED. A CMC (AFOCUS II; 7F, 15 MM DIAMETER; ST. JUDE MEDICAL, (B)(4)) WAS PLACED THROUGH A STEERABLE SHEATH (FLEXCATH ADVANCE; 12F INNER DIAMETER; MEDTRONIC, (B)(4)) TO CONFIRM PV ISOLATION AT THE END OF THE PROCEDURE. UPON REMOVAL OF THE CMC FROM THE LA WITH SIGNIFICANT EXERTION OWING TO RESISTANCE, A FREEFLOATING METALLIC ELECTRODE THAT HAD DISPLACED FROM THE CMC WAS SEEN ON FLUOROSCOPY FREE-FLOATING WITHIN THE LA (FIGURE 1A¿D, SUPPLEMENTAL VIDEO 1). THIS CATHETER WAS REMOVED AND THE ABSENCE OF THE DISTAL POLE WAS OBSERVED. WHILE WE WERE WAITING FOR THE OPERATING THEATRE TO BE READY, THE ELECTRODE HAD SURPRISINGLY TRAVELED RETROGRADE AND BECOME LODGED IN A TERMINAL BRANCH OF THE RIPV, AS SEEN ON FLUOROSCOPY (FIGURE 1E, F, SUPPLEMENTAL VIDEO 2) AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (FIGURE 1G, H). REPEAT IMAGING DURING 12-MONTH FOLLOW-UP CONFIRMED THAT THE ELECTRODE HAD NOT MIGRATED ANY FURTHER, AND THE PATIENT REMAINED ASYMPTOMATIC, WITH NO SIGNIFICANT MITRAL REGURGITATION ON ECHOCARDIOGRAPHY." (HTTP://DX.DOI.ORG/10.1016/J.HRCR.2017.06.001., ELVESIER LTD.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900167 INQUIRY¿ ELECTROPHYSIOLOGY CATHETER, INQUIRY¿ AFOCUS II¿ EB CATHETER, 110 CM LEN ELECTRODE RECORDING CATHETER DRF ST. JUDE MEDICAL, INC. D087023

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other