BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATH PKGD: WEDGE 6 FR 110 CM

    MDR report key: 18444330 · Received January 4, 2024

    Report

    Report Number
    3010532612-2024-00010
    Event Type
    Death
    Date Received
    January 4, 2024
    Date of Event
    July 25, 2023
    Report Date
    December 7, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DYG
    UDI-DI
    00801902002877
    PMA / PMN Number
    K892530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4), THE REPORTED COMPLAINT OF CATHETER DIFFICULT TO ADVANCE IN PATIENT IS NOT ABLE TO BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    RECEIVED VIA A MEDWATCH REPORT, SUBMITTED BY THE RISK MANAGER AT THE HEALTH CARE FACILITY, THE REPORT STATES "WITH ULTRASOUND GUIDANCE, WE OBTAINED ACCESS TO THE RIGHT COMMON FEMORAL ARTERY AND VEIN WITH MICRO PUNCTURE NEEDLE AND THEN ADVANCED A 6 FR SHEATH OVER A WIRE IN EACH USING THE SELDINGER APPROACH. ARROW CATHETER WAS ADVANCED IN THE PULMONARY ARTERY AND USED TO OBTAIN HEMODYNAMICS MEASUREMENTS. DURING CATHETER ADVANCEMENT OVER A J-WIRE TO OBTAIN ACCURATE PULMONARY WEDGE PRESSURE, PATIENT DECOMPENSATED AND WENT INTO RESPIRATORY ARREST WITH HEMOPTYSIS AND ASPIRATION. THIS COULD HAVE BEEN SECONDARY TO POSSIBLE CATHETER INDUCED PULMONARY ARTERY RUPTURE AND PULMONARY HEMORRHAGE. DESPITE ALL EMERGENT CARDIOPULMONARY RESUSCITATION EFFORTS PATIENT EXPIRED". THE MEDWATCH REPORT STATES THAT THE PATIENT WAS AN "84 [YEAR OLD] FEMALE WITH HISTORY OF HTN, HLP, HFPEF, MODERATE VALVULAR DISEASE AND COPD/OSA ADMITTED FOR CHEST PAIN AND SOB. PRIOR HISTORY OF CARDIAC CATHETERIZATION IN 2021, WITH MILD DISEASE AND ECHO IN 2021 SHOWING AS AND AI. REPEAT ECHO IN 6/23 SHOWED PRESERVED EF AND MODERATE AS. SHE WAS SCHEDULED FOR OP PROCEDURE BUT HER SYMPTOMS GOT WORSE WARRANTING HER TO COME TO THE EMERGENCY DEPARTMENT. EKG SHOWED SINUS BRADYCARDIA WITH T-WAVE INVERSION. HS TROP 52-49-52, PRO BNP 7183. CXR SHOWS CARDIOMEGALY AND MILD PULMONARY EDEMA". ADDITIONAL INFORMATION RECEIVED FROM THE RISK MANAGER AT THE HEALTH CARE FACILITY STATES THAT THE CAUSE OF DEATH WAS "UNDETERMINED".

    Description of Event or Problem · 0

    RECEIVED VIA A MEDWATCH REPORT, SUBMITTED BY THE RISK MANAGER AT THE HEALTH CARE FACILITY, THE REPORT STATES "WITH ULTRASOUND GUIDANCE, WE OBTAINED ACCESS TO THE RIGHT COMMON FEMORAL ARTERY AND VEIN WITH MICRO PUNCTURE NEEDLE AND THEN ADVANCED A 6 FR SHEATH OVER A WIRE IN EACH USING THE SELDINGER APPROACH. ARROW CATHETER WAS ADVANCED IN THE PULMONARY ARTERY AND USED TO OBTAIN HEMODYNAMICS MEASUREMENTS. DURING CATHETER ADVANCEMENT OVER A J-WIRE TO OBTAIN ACCURATE PULMONARY WEDGE PRESSURE, PATIENT DECOMPENSATED AND WENT INTO RESPIRATORY ARREST WITH HEMOPTYSIS AND ASPIRATION. THIS COULD HAVE BEEN SECONDARY TO POSSIBLE CATHETER INDUCED PULMONARY ARTERY RUPTURE AND PULMONARY HEMORRHAGE. DESPITE ALL EMERGENT CARDIOPULMONARY RESUSCITATION EFFORTS PATIENT EXPIRED". THE MEDWATCH REPORT STATES THAT THE PATIENT WAS AN "84 [YEAR OLD] FEMALE WITH HISTORY OF HTN, HLP, HFPEF, MODERATE VALVULAR DISEASE AND COPD/OSA ADMITTED FOR CHEST PAIN AND SOB. PRIOR HISTORY OF CARDIAC CATHETERIZATION IN 2021, WITH MILD DISEASE AND ECHO IN 2021 SHOWING AS AND AI. REPEAT ECHO IN 6/23 SHOWED PRESERVED EF AND MODERATE AS. SHE WAS SCHEDULED FOR OP PROCEDURE BUT HER SYMPTOMS GOT WORSE WARRANTING HER TO COME TO THE EMERGENCY DEPARTMENT. EKG SHOWED SINUS BRADYCARDIA WITH T-WAVE INVERSION. HS TROP 52-49-52, PRO BNP 7183. CXR SHOWS CARDIOMEGALY AND MILD PULMONARY EDEMA". ADDITIONAL INFORMATION RECEIVED FROM THE RISK MANAGER AT THE HEALTH CARE FACILITY STATES THAT THE CAUSE OF DEATH WAS "UNDETERMINED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567936 CATH PKGD: WEDGE 6 FR 110 CM CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL LLC 16F23D0043 00801902002877

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Death