BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERWIRE RADIOFREQUENCY GUIDEWIRE

    MDR report key: 11132649 · Received January 7, 2021

    Report

    Report Number
    9710452-2020-00066
    Event Type
    Death
    Date Received
    January 7, 2021
    Report Date
    February 12, 2021
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    PDU
    PMA / PMN Number
    K101615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION IS A FOLLOW-UP REPORT FOR THE MANUFACTURER REPORT NUMBER: 9710452-2020-00066 SUBMITTED ON JAN. 7. 2021. IT WAS FOUND THAT THE ADVERSE EVENTS FROM THE LITERATURE SOURCE WERE PREVIOUSLY SUBMITTED TO THE FDA BY BAYLIS MEDICAL COMPANY INC. ON SEPTEMBER 22, 2017 UNDER THE MANUFACTURER REPORT NUMBER: 9710452-2017-00024, THEREFORE MANUFACTURER REPORT NUMBER: 9710452-2020-00066 IS A DUPLICATE REPORT.

    Additional Manufacturer Narrative · 1

    THERE IS NO SUSPECTED DEVICE FAILURE. THE REPORTED ADVERSE EVENT IS AN INHERENT RISK IN THIS TYPE OF PROCEDURE.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, AN ARTICLE [1] WAS IDENTIFIED IN WHICH A PATIENT HAD AN INADVERTENT TRACHEAL PERFORATION BY THE POWERWIRE RF GUIDEWIRE IN A CENTRAL VENOUS OCCLUSION (CVO) RECANALIZATION PROCEDURE. AS PER THE PUBLISHED ARTICLE: "DURING ATTEMPTED REVASCULARIZATION OF A LONG-SEGMENT LEFT BRACHIOCEPHALIC VEIN OCCLUSION NEAR THE MIDLINE USING THE RF WIRE, SANGUINEOUS EXCRETIONS WERE SEEN COMING FROM THE ENDOTRACHEAL TUBE (ET). THIS WAS DUE TO INADVERTENT TRACHEAL PERFORATION. IN THE ANGIOGRAPHY SUITE, THE ET TUBE WAS POSITIONED BELOW THE ESTIMATED TRACHEAL PERFORATION SITE. THIS IMPROVED THE PATIENT'S OXYGEN SATURATION TO 100% WITH THE OTHER VITAL SIGNS REMAINING STABLE. AT THIS POINT, THE PROCEDURE WAS TERMINATED. THE PATIENT SUBSEQUENTLY UNDERWENT EMERGENT BRONCHOSCOPY, WHICH REVEALED TWO SMALL ANTERIOR TRACHEAL MUCOSAL LESIONS OOZING BLOOD WITHOUT FRANK ARTERIAL BLEEDING. THE ET TUBE WAS POSITIONED TO TAMPONADE THIS AREA. DESMOPRESSIN ACETATE (DDAVP) WAS ADMINISTERED AND THE PATIENT WAS TRANSFERRED TO THE MEDIAL INTENSIVE CARE UNIT FOR FURTHER CARE. A CHEST CTA REVEALED A MEDIASTINAL HEMATOMA WITH NO ACTIVE EXTRAVASATION (FIG. 4). THE PATIENT WAS EXTUBATED 8 DAYS POSTINTERVENTION BUT DIED LATER DURING THE HOSPITALIZATION DUE TO A COMBINATION OF CO-MORBIDITIES AND REFUSAL OF FURTHER CARE." THERE IS NO SUSPECTED DEVICE FAILURE. THE REPORTED ADVERSE EVENT IS AN INHERENT RISK IN THIS TYPE OF PROCEDURE. [1] SIVANANTHAN, G., D. H. MACARTHUR, K. P. DALY, D. W. ALLEN, S. HAKHAM, AND N. J. HALIN. 2015. 'SAFETY AND EFFICACY OF RADIOFREQUENCY WIRE RECANALIZATION OF CHRONIC CENTRAL VENOUS OCCLUSIONS', J VASC ACCESS, 16: 309-14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28974 POWERWIRE RADIOFREQUENCY GUIDEWIRE PERCUTANEOUS CATHETER PDU BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R