BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 20602747 · Received November 4, 2024

    Report

    Report Number
    3004936110-2024-01365
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    October 15, 2024
    Report Date
    February 21, 2025
    Manufacturer
    ABBOTT MEDICAL. - CARDIOMEMS
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 0

    ONE ABBOTT CATHETER ASSEMBLY WITH TETHERED SENSOR AND GUIDEWIRE ADVANTAGE GUIDEWIRE UNLOADED FROM CATHETER WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE HUB AND THE LENGTH OF THE CATHETER WERE FOUND TO BE NORMAL. THE OUTER DIAMETER OF THE CATHETER MEASURED TO BE WITHIN SPECIFICATION PER 90173057 REV. B AT 0.0470 IN. AT THE PROXIMAL END AND 0.0475 IN. AT THE DISTAL TIP BY A THICKNESS GAUGE (ASSET ID 109249). INSPECTION OF THE SKIVING PORTION OF THE CATHETER SHOWED NO ABNORMALITIES AND THE CORRECT TETHER PATTERN FOR THE SENSOR WHEN VERIFIED AGAINST CS-001163 REV. S (PER OP-600504 REV. AP STEP 8.3.5). VISUAL INSPECTION OF THE SENSOR SHOWED NO ABNORMALITIES. THE WIDTH OF THE SENSOR WAS FOUND TO BE WITHIN SPECIFICATION PER CS-000553 REV. U WITH A WIDTH OF 2.04MM, 2.05MM, AND 2.05MM DETERMINED BY A DIGITAL CALIPER (ASSET ID 198601). THE RETURNED 0.018¿ GLIDEWIRE ADVANTAGE GUIDEWIRE WAS PASSED THROUGH THE ENTIRETY OF THE CATHETER LENGTH WITH NO DIFFICULTY. THE THICKNESS OF THE GUIDEWIRE WAS ALSO MEASURED TO BE 0.017 IN. USING THICKNESS GAUGE (ASSET ID 109249). THE RESULTS OF THE INVESTIGATION ARE THAT THERE ARE NO PRODUCT ABNORMALITIES IDENTIFIED WITH THE CARDIOMEMS DELIVERY SYSTEM THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE DHR WAS PERFORMED FOR BATCH 10398123 AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE. TWO NONCONFORMANCES WERE FOUND IN THE BATCH RECORDS REVIEWED, BUT NONE WERE RELATED TO THE REPORTED EVENT. A LOT REVIEW WAS PERFORMED VIA COMPLAINT HANDLING SYSTEM (EPIQ) USING A SEARCH OF BATCH 10398123. CONCLUSIVELY, THERE ARE SIX ADDITIONAL COMPLAINTS RELATED TO THE ASSOCIATED BATCH, BUT TWO WERE RELATED TO THE REPORTED EVEN.

    Description of Event or Problem · 0

    DURING A CARDIOMEMS IMPLANT PROCEDURE, THE CARDIOMEMS DELIVERY CATHETER WAS ADVANCED OVER AN 0.018" X 300 CM GLIDEWIRE ADVANTAGE. BEFORE THE DELIVERY CATHETER ENTERED THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THE PATIENT BEGAN TO COUGH AND WAS FOUND TO HAVE BLOOD IN THEIR MOUTH. THE PROCEDURE WAS THEN ABANDONED DUE TO THE HEMOPTYSIS. THE ABBOTT REP CONFIRMED THAT NO INTERVENTIONS WERE NEEDED TO STOP THE HEMOPTYSIS, AND THE PHYSICIAN FELT THAT THE CAUSE OF THE HEMOPTYSIS WAS DAMAGE TO THE DISTAL PULMONARY ARTERY CAUSED BY THE GLIDEWIRE ADVANTAGE. THE PATIENT WAS ADMITTED TO THE ICU AFTER THE PROCEDURE FOR MONITORING AND RELEASED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46895 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL. - CARDIOMEMS CM2000 10398123 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization