BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 17030958 · Received May 31, 2023

    Report

    Report Number
    3004936110-2023-00550
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    May 8, 2023
    Report Date
    September 19, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS DELIVERY SYSTEM CATHETER WITH TETHERED SENSOR WERE RECEIVED FOR RETURN. THE VISUAL INSPECTION OF THE LENGTH OF THE CATHETER SHOWED PROMINENT KINKING CONSISTENT WITH DAMAGE DURING USE.. THERE WERE NO ABNORMALITIES OBSERVED WITH THE HUB OF THE CATHETER. THE TETHERING PATTERN WAS CORRECT WHEN VERIFIED AGAINST CS-001163 REV. P (PER OP-600504 REV. AM STEP 8.3.4). THE SENSOR SHOWED NO GROSS DAMAGE DURING THE VISUAL INSPECTION. THE GUIDEWIRE WAS NOT RETURNED AND COULD NOT BE INVESTIGATED FOR CONTRIBUTION TO EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT DESCRIPTION. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE ANGIOGRAM CONFIRMED PERFORATION LOCATION WAS A VESSEL IN THE LEFT PULMONARY ARTERY. THE PATIENT WAS DISCHARGED (B)(6) 2023.

    Description of Event or Problem · 0

    DURING CARDIOMEMS IMPLANT, THE PATIENT EXPERIENCED HEMOPTYSIS JUST AS THE CARDIOMEMS DELIVERY SYSTEM WAS BEING INSERTED THROUGH THE SHEATH. THE PROCEDURE WAS ABANDONED. THE PATIENT WAS ELEVATED AND STABILIZED USING SUCTION. OXYGEN WAS ADMINISTERED AND THE PATIENT WAS HELD OVERNIGHT FOR OBSERVATION. AN ANGIOGRAM WAS PERFORMED AND CONFIRMED PERFORATION. THE PHYSICIAN REPORTED THEY BELIEVE THE CAUSE OF THE HEMOPTYSIS WAS THE GUIDEWIRE AND REPORTED THAT THE PATIENT'S LEFT PULMONARY ARTERY WAS DIFFICULT TO WIRE DOWN INTO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160650 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000 8253598 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention| H