BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERWIRE RADIOFREQUENCY GUIDEWIRE

    MDR report key: 11132637 · Received January 7, 2021

    Report

    Report Number
    9710452-2020-00065
    Event Type
    Injury
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUBMISSION IS A FOLLOW-UP REPORT FOR THE MANUFACTURER REPORT NUMBER 9710452-2020-00065 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 MAY 8, 2019 UNDER THE MANUFACTURER REPORT NUMBER 9710452-2019-00012, THEREFORE MANUFACTURER REPORT NUMBER 9710452-2020-00065 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 THE SUPERIOR VENA CAVA WAS PERFORATED INTO THE PERICARDIAL SPACE IN A CHRONIC VENOUS OCCLUSION PROCEDURE WHERE THE POWERWIRE RF GUIDEWIRE WAS USED AMONG OTHER DEVICES INCLUDING DORADO, CONQUEST AND ATLAS BALLOON CATHETERS (BARD PERIPHERAL VASCULAR) AND S.M.A.R.T STENTS (CORDIS/CARDINAL HEALTH). THE COMPLICATION WAS SUCCESSFULLY MANAGED WITH ANTICOAGULATION REVERSAL, OVERNIGHT OBSERVATION, AND ORAL ANTI-INFLAMMATORY THERAPY FOR PROCEDURE-INDUCED PERICARDITIS. THERE WAS NO LONG-TERM DETRIMENTAL EFFECTS AND FURTHER INTERVENTION WAS ABORTED. THERE IS NO SUSPECTED DEVICE FAILURE. THE REPORTED ADVERSE EVENT IS AN INHERENT RISK IN THIS TYPE OF PROCEDURE. [1] KELLER, E. J., S. A. GUPTA, S. BONDAREV, K. T. SATO, R. L. VOGELZANG, AND S. A. RESNICK. 2018. 'SINGLE-CENTER RETROSPECTIVE REVIEW OF RADIOFREQUENCY WIRE RECANALIZATION OF REFRACTORY CENTRAL VENOUS OCCLUSIONS', J VASC INTERV RADIOL, 29: 1571-77.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28485 POWERWIRE RADIOFREQUENCY GUIDEWIRE PERCUTANEOUS CATHETER PDU BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R