BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM

    MDR report key: 20088062 · Received August 28, 2024

    Report

    Report Number
    3024985933-2024-00005
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 1, 2024
    Report Date
    May 15, 2025
    Manufacturer
    ENDOTRONIX, INC
    Product Code
    MOM
    UDI-DI
    00850008997006
    PMA / PMN Number
    P230040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION G3: INITIAL REPORT DATE RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION(S): B5, G6 AND H3: SECTION B5: DURING THE PATIENT'S FOLLOW-UP CLINIC VISIT ON (B)(6) 2024, THE ENDOTRONIX CLINICAL SPECIALIST ATTEMPTED TO TAKE A READING BY PLACING THE READER ON THE PATIENT'S CHEST, BACK, SHOULDER, AND UNDER THE ARM. THE SIGNAL STRENGTH ON THE TABLET SHOWED 0%. THE ENDOTRONIX CLINICAL SPECIALIST MOVED DOWN TO THE PATIENT'S OUTER THIGH, AND IT LOCKED ONTO THE PA SENSOR SIMILAR TO PREVIOUS RESULTS TAKEN ON (B)(6) 2024 AT PATIENT'S HOME VISIT BY ENDOTRONIX SERVICING ENGINEER. THE ENDOTRONIX CLINICAL SPECIALIST SPOKE WITH THE PHYSICIAN AND HE WAS ABLE TO FIND A CT FROM (B)(6) 2024 THAT CONFIRMED THAT THE PA SENSOR IS STILL AT THE DOWNTURN OF THE RIGHT PULMONARY ARTERY (RPA) AND THAT THE POSITION HAS NOT CHANGED FROM THE INITIAL IMPLANT. THE CLINICAL SPECIALIST INFORMED THE PHYSICIAN THAT THE FREQUENCY IS MOST LIKELY OUT OF OUR RANGE, SO THE PATIENT WON'T BE ABLE TO TAKE READINGS. THE CAUSE OF THIS IS UNDER INVESTIGATION. THE PATIENT WILL REMAIN IN THE STUDY AND CONTINUE TO TAKE VITALS (BLOOD PRESSURE, WEIGHT AND PULSE OXIMETRY), BUT WILL NO LONGER TAKE PA READINGS. ADDITIONAL INFORMATION WILL BE SUBMITTED VIA FOLLOW-UP REPORT WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    (H3) THE SENSOR WAS NOT RETURNED AS IT REMAINS IMPLANTED. THE PATIENT WAS IMPLANTED WITH SENSOR (B)(6) ON 2022-10-03 (668 DAYS PRIOR TO EVENT DATE). STARTING IN(B)(6) 2023, MEAN PULMONARY ARTERIAL PRESSURE (MPAP) TREND STARTED DECREASING FROM APPROXIMATELY 10 MMHG TO -30 MMHG BY (B)(6) 2023. A RECALIBRATION WAS PERFORMED ON (B)(6) 2023, WHICH SHOWED THE CORDELLA SENSOR WAS MEASURING PRESSURES 39 MMHG LOWER THAN THE FLUID-FILLED REFERENCE. IN(B)(6) 2023, ENDOTRONIX FLAGGED SENSOR (B)(6) BECAUSE PA PRESSURES WERE TRENDING DOWNWARD. ON (B)(6) 2024, A FIELD SERVICE ENGINEER VISITED THE PATIENT AND CONFIRMED THAT A READING COULD NOT BE TAKEN. ANOTHER VISIT WAS SCHEDULED AT THE SITE, WHICH AGAIN CONFIRMED THAT A READING COULD NOT BE TAKEN, EVEN WHEN A DIFFERENT READER (R002094) WAS USED. A REVIEW OF CT IMAGES REVEALED THAT THE SENSOR'S DISTAL ANCHOR IS LODGED IN A SMALL, ANTERIORLY AND MEDIALLY ORIENTED VESSEL (A BACK TURN CREATES THE APPEARANCE OF A NON-ANTERIOR ORIENTATION). THIS POSITIONING EXERTS SIGNIFICANT FORCE ON THE SENSOR, PRESSING IT AGAINST THE OPPOSITE (CRANIAL) VESSEL WALL. ADDITIONALLY, THE PROXIMAL ANCHOR IS SITUATED IN A MORE PROXIMAL BRANCH. THESE FINDINGS INDICATE THAT THE POSITIONING AND DEPLOYMENT OF THE SENSOR IS SUBOPTIMAL. THE EXTERNAL MECHANICAL FORCE EXERTED BY THE PULMONARY ARTERY VESSEL WALL WAS LIKELY PRESENT DURING THE TIME OF INITIAL CALIBRATION. THIS EXERTED FORCE SLOWLY DECREASED FOLLOWING IMPLANT, WHICH LIKELY CAUSED A DECREASE IN THE PRESSURE MEASURED AND REPORTED BY THE SENSOR. BASED ON THE POSITIONAL EVIDENCE OBSERVED IN THE IMAGING, THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE PHYSICIAN POSITIONING AND DEPLOYING OF THE SENSOR IS SUBOPTIMAL.

    Description of Event or Problem · 0

    IN (B)(6) 2024, THE PATIENT WAS UNABLE TO TAKE PA READINGS WITH HIS MYCORELLA READER. ON (B)(6) 2024, AN ENDOTRONIX SERVICING ENGINEER CONDUCTED A HOME VISIT AND NOTED THAT HE WAS UNABLE TO LOCK THE READER TO THE SENSOR SIGNAL. HE TRIED DIFFERENT POSITION SON THE CHEST, COLLAR BONE, SIDE AND BACK WITHOUT SUCCESS. PATIENT IS CURRENTLY UNABLE TO TAKE PA READINGS AND CONTINUES TO BE TREATED PER HEART FAILURE STANDARD OF CARE. THERE HAS BEEN NO REPORTED PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548769 CORDELLA¿ PULMONARY ARTERY SENSOR SYSTEM PULMONARY ARTERY SENSOR MOM ENDOTRONIX, INC 00850008997006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male