BEUDAMED
    FDA Adverse Event Other Summary report: N

    V18 GUIDEWIRE

    MDR report key: 17278605 · Received July 6, 2023

    Report

    Report Number
    MW5119161
    Event Type
    Other
    Date Received
    July 6, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING CARDIOMEMS IMPLANT PROCEDURE THE PATIENT EXPERIENCED HEMOPTYSIS SHORTLY AFTER SENSOR DEPLOYMENT. THE PHYSICIAN REPORTED THIS WAS A VERY TECHNICALLY CHALLENGING PROCEDURE. THE PATIENT HAD SEVERE TRICUSPID REGURGITATION WITH A LARGE RIGHT ATRIUM MAKING IT DIFFICULT TO SECURELY TRACK WITH A WIRE TO THE PULMONARY ARTERY AND LEADING TO TENSION ON THE WIRE (V18) CAUSING THE CARDIOMEMS CATHETER TO SHOOT FORWARD AND LIKELY CAUSE A PULMONARY ARTERY ABRASION. THE PATIENT WAS RETAINED FOR OBSERVATION AND RELEASED (B)(6) 2023. AN ANGIOGRAM WAS PERFORMED AND CONFIRMED THAT THERE WAS NO PERFORATION. THE SENSOR WAS NOT CALIBRATED DURING THE IMPLANT DUE TO THE REQUIRED INTERVENTION FOR THE HEMOPTYSIS. AN ADDITIONAL RIGHT HEART CATHETERIZATION WAS PERFORMED ON (B)(6) 2023 TO CALIBRATE THE SENSOR. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421367 V18 GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown