BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN CARDIAC MATERIAL

    MDR report key: 20151429 · Received September 5, 2024

    Report

    Report Number
    3010532612-2024-00736
    Event Type
    Death
    Date Received
    September 5, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). MEDWATCH REPORT #: MW5158024.

    Additional Manufacturer Narrative · 0

    QN #(B)(4). MEDWATCH REPORT #: MW5158024. CORRECTED DATA: SECTION H.1.-TYPE OF REPORTABLE EVENT CORRECTED TO "DEATH" BASED ON MEDWATCH REPORT RECEIVED. THE REPORTED COMPLAINT THAT THE CATHETER WAS DIFFICULT TO ADVANCE IN THE PATIENT IS NOT ABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH "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". NO ADDITIONAL INFORMATION SURROUNDING THE CIRCUMSTANCES OF THIS EVENT ARE AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH "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". NO ADDITIONAL INFORMATION SURROUNDING THE CIRCUMSTANCES OF THIS EVENT ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073803 UNKNOWN CARDIAC MATERIAL SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death N/A.| N/A.