BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSPC NXT DELIVERY CATHETER

    MDR report key: 23821226 · Received December 16, 2025

    Report

    Report Number
    3015970743-2025-00007
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 16, 2025
    Manufacturer
    CENTERPOINT SYSTEMS LLC
    Product Code
    DQY
    PMA / PMN Number
    K243180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THE COMPLAINT INFORMATION, CENTERPOINT INQUIRED FOR ADDITIONAL INFORMATION AS THE COMPLAINT APPEARED TO BE RELATED TO A DEVICE NOT MANUFACTURED BY CENTERPOINT SYSTEMS. CENTERPOINT CONFIRMED FROM THE DISTRIBUTOR THAT THE PHYSICIAN SAVED THE DEVICE THAT MALFUNCTIONED (SLITTER NOT MANUFACTURED BY CENTERPOINT) INDICIATING THAT NO CENTERPOINT DEVICE MALFUNCTIONED DURING THE EVENT. THE SSPC NXT DELIVERY CATHETER THAT WAS USED DURING THE EVENT WAS NOT RETURNED NOR WAS A LOT NUMBER PROVIDED FOR FURTHER INVESTIGATION. THE INVESTIGATION INVOLVED ANALYSIS OF RELVEANT INFORMATION PROVIDED BY THE HEALTHCARE PROFESSIONAL AND DISTRIBUTOR. BASED ON THE INFORMATION PROVIDED, IT WAS CONFIRMED THAT THE REPORTED PATIENT HARM WAS NOT ATTRIBUTED TO A DEFECT OR MALFUNCTION OF THE SSPC NXT DELIVERY CATHETER. CENTERPOINT SYSTEMS IS REPORTING THE EVENT OUT OF CAUTION TO COMPLY WITH APPLICABLE REGULATORY REQUIREMENTS DUE TO THE PATIENT OUTCOME, EVEN THOUGH THE MANUFACTURER OF THE DEVICE INVOLVED IS NOT CENTERPOINT SYSTEMS.

    Description of Event or Problem · 0

    CUTTER ISSUE IDENTIFIED DURING PROCEDURE YESTERDAY AT ST CHARLES MEDICAL CENTER, BEND, OR WITH DR CHRISTOPHER LEWIS. LBB IMPLANT WITH THE SSPC NXT CATHETER. WHEN THE MD WENT TO CUT THE CATHETER, THE TIP OF THE BLADE BROKE OFF WHICH PULLED THE LBB LEAD OUT AS WELL AS THE TEMPERORARY PACING LEAD. PATIENT WENT SYSTOLIC WHICH REQUIRED EXTERNAL PACING. THIS INDUCED THE PATIENT INTO VT AND THE PATIENT REQUIRED EXTERNAL SHOCK TO RESCUE. HAVE THE CUTTER. WILL BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444933 SSPC NXT DELIVERY CATHETER PERCUTANEOUS CATHETER DQY CENTERPOINT SYSTEMS LLC 9286

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R