BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPS LOCATOR 3D DELIVERY CATHETER

    MDR report key: 23763384 · Received December 9, 2025

    Report

    Report Number
    3015970743-2025-00005
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 9, 2025
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    PMA / PMN Number
    K230363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DOCUMENTATION INVESTIGATION DID NOT IDENTIFY ANY KNOWN NONCONFORMITIES. ANALYSIS OF THE RETURNED DEVICE AND ADDITIONAL TESTING RESULTED IN CONFIDENCE THAT THIS WAS AN ISOLATED INCIDENT. A FINAL ROOT CAUSE COULD NOT BE DETERMINED. BASED ON RISK ANALYSIS AND INVESTIGATION RESULTS, NO FURTHER ACTION IS REQUIRED. NO PATIENT HARM WAS IDENTIFIED, AND CENTERPOINT IS REPORTING OUT OF CAUTION TO ENSURE COMPLIANCE TO RELEVANT REQUIREMENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2025 AT (B)(6) HOSPITAL, DR. (B)(6) PERFORMED AN IPG CPS CASE USING ABBOTT'S 3D CPS LOCATOR MEDIUM SIZE SHEATH. WHEN HE TRIED TO APPROACH THE SHEATH FOR LBBAP TARGET AREA, THE SHEATH BODY WAS FRACTURED IN TWO PARTS IN THE PATIENT'S RV CAVITY. PHYSICIAN INSISTED THAT HE DIDN'T GIVE ANY EXCESSIVE PRESSURE OR FORCE TO THE SHEATH BUT ONLY TRIED TO PULL THE SHEATH UP FOR BETTER APPROACH AND AN INFERIOR PART OF FRACTURED SHEATH WAS COMPLETELY DIVIDED FROM THE SUPERIOR PART OF THE SHEATH BODY. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN DECIDED TO PULL UP THE SUPERIOR PORTION OF THE FRACTURED SHEATH OUT OF THE PATIENT'S ENDOCARDIUM BUT THE RESIDUAL PORTION OF THE SHEATH STILL REMAINED IN THE PATIENT'S RA&RV CAVITY. AS A RESULT, PHYSICIAN SUCCEEDED TO RETRIEVE THE RESIDUAL PORTION OF THE SHEATH USING A SNARE. HE PUNCTURED FEMORAL JUNCTION AND INSERTED 16FR SHEATH UNTIL IVC. THROUGH THE SNARE HE CAUGHT THE RESIDUAL SHEATH BODY AND FOLDED IT ALMOST BY 180 DEGREES AND PULLED IT OUT FROM THE BODY THROUGH THE 16FR SHEATH. THE PATIENT DIDN'T HAVE ANY COMPLICATIONS BUT PHYSICIAN CLAIMED ABOUT PRODUCT PROBLEM. DISTRIBUTOR RETRIEVED IT AND DELIVERED IT FOR RETURN PROCESS. THE CASE WAS FINISHED BY CONVENTIONAL IPG PROCEDURE (RV APEX POSITIONING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526040 CPS LOCATOR 3D DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC DS2C200-42 CL13726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown