BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW SWAN GANZ CATHETER

    MDR report key: 19918548 · Received August 5, 2024

    Report

    Report Number
    MW5158024
    Event Type
    Death
    Date Received
    August 5, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 2, 2024
    Manufacturer
    ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
    Product Code
    DYG
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMOPTYSIS DURING THE CARDIOMEMS IMPLANT PROCEDURE AND THAT THE PATIENT DIED. DURING PROCEDURE THE PHYSICIAN GAINED ACCESS AND PROCEEDED TO USE A 0.18 GUIDEWIRE. THE PHYSICIAN ADVANCED THE WIRE TO THE PULMONARY ARTERY. THE PHYSICIAN USED AN ARROW SWAN GANZ CATHETER OVER THE WIRE. THE PATIENT COUGHED A FEW TIMES, BUT THE PHYSICIAN PROCEEDED WITH THE RIGHT HEART CATHETERIZATION. IT WAS THEN THAT THE PATIENT EXPERIENCED HEMOPTYSIS. THE PATIENT'S STATUS WAS DETERIORATING SO THE CODE TEAM WAS CALLED IN TO TRY TO RESUSCITATE THE PATIENT. THE PHYSICIAN DID A THORACOTOMY TO TRY TO STOP THE BLEEDING. THE PATIENT DIED IN THE CATH LAB. THE CARDIOMEMS SENSOR WAS NOT OPENED OR INSERTED INTO THE BODY. NO SPECIFIC CAUSE OF DEATH WAS LISTED IN THE PATIENT¿S CHART. THE PHYSICIAN BELIEVED THAT THERE MUST HAVE BEEN A PERFORATION, BUT ONE COULD NOT BE IDENTIFIED. 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
    1560044 ARROW SWAN GANZ CATHETER CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death