BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERWIRE RADIOFREQUENCY GUIDEWIRE

    MDR report key: 8593730 · Received May 8, 2019

    Report

    Report Number
    9710452-2019-00012
    Event Type
    Injury
    Date Received
    May 8, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BAYLIS MEDICAL COMPANY INC.
    Product Code
    PDU
    PMA / PMN Number
    K101615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT. THERE IS NO SUSPECTED DEVICE FAILURE. THE REPORTED PATIENT COMPLICATION IS AN INHERENT RISK IN THIS TYPE OF PROCEDURE.

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENT WAS IDENTIFIED IN A SCIENTIFIC ARTICLE: KELLER, ERIC J., ET AL. "SINGLE-CENTER RETROSPECTIVE REVIEW OF RADIOFREQUENCY WIRE RECANALIZATION OF REFRACTORY CENTRAL VENOUS OCCLUSIONS." JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY 29.11 (2018): 1571-1577. THE POWERWIRE RADIOFREQUENCY GUIDEWIRE WAS USED IN A PROCEDURE FOR RECANALIZATION OF A CENTRAL VENOUS OCCLUSION (CVO). FOLLOWING APPARENT CVO TRAVERSAL, VENOGRAPHY REVEALED WIRE AND CATHETER ENTRY INTO THE PERICARDIAL SPACE. THIS WAS SUCCESSFULLY MANAGED CONSERVATIVELY WITH ANTICOAGULATION REVERSAL, OVERNIGHT OBSERVATION, AND ORAL ANTI-INFLAMMATORY THERAPY FOR PROCEDURE-INDUCED PERICARDITIS, WITH NO LONG-TERM DETRIMENTAL EFFECTS, BUT FURTHER INTERVENTION WAS ABORTED. THERE IS NO EVIDENCE TO SUGGEST THAT THE BAYLIS MEDICAL DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, AS THE BAYLIS MEDICAL DEVICE WAS REPORTED TO BE AMONG THE DEVICES USED IN THE PROCEDURE, BAYLIS MEDICAL HAS DECIDED TO SUBMIT THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387039 POWERWIRE RADIOFREQUENCY GUIDEWIRE PERCUTANEOUS CATHETER PDU BAYLIS MEDICAL COMPANY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention