BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELIVERY CATHETER SSPC3

    MDR report key: 23855602 · Received December 19, 2025

    Report

    Report Number
    2124215-2025-92122
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 27, 2025
    Report Date
    May 25, 2026
    Manufacturer
    CENTERPOINT SYSTEMS
    Product Code
    DQY
    UDI-DI
    00810024671830
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS AND SENT TO THE SFMD SUPPLIER FOR ANALYSIS. DEVICE HISTORY REVIEW - A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE REQUIRED DOCUMENTATION WAS UNAVAILABLE SINCE THE PRODUCT WAS MANUFACTURED OUTSIDE OF BOSTON SCIENTIFIC. IF THE APPLICABLE DOCUMENTATION BECOMES AVAILABLE, THE INVESTIGATION RECORD WILL BE RE-OPENED AND UPDATED ACCORDINGLY WITH THE RESULTS OF THE DEVICE HISTORY RECORD (DHR) REVIEW. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF UNABLE TO EXCLUDE DEVICE PROBLEM BASED ON THE LACK OF OBJECTIVE EVIDENCE OF A DEVICE DEFECT OR MALFUNCTION. THEREFORE, IT CAN BE CONCLUDED THAT UNKNOWN FACTORS MOST PROBABLY CONTRIBUTED TO THE EVENT. THIS REPORT IS BEING SUBMITTED TO CORRECT THE UNIQUE IDENTIFIER (UDI) # FIELD (D4) IN SECTION D, SUSPECT MEDICAL DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CHECK VALVE COMPONENT OF THIS ACCESSORY GUIDE CATHETER DETACHED AND REMAINED WHEN SECURING THE RIGHT VENTRICULAR LEAD TO THE SUCTION SLEEVE. THE ATTENDING PHYSICIAN VERIFIED THE DETACHED COMPONENT TO BE SIMILAR WITH THE TRANSLUCENT RING SHAPED PART FROM A NEW GUIDE CATHETER. THE INVOLVED RV LEAD DID NOT EXHIBIT LEAD DISLODGEMENT WITH NORMAL LEAD DATA MEASUREMENTS AS REPEATEDLY CHECKED WITH NO SIGNIFICANT CHANGES. THIS ACCESSORY WAS OUT OF SERVICE AND WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CHECK VALVE COMPONENT OF THIS ACCESSORY GUIDE CATHETER DETACHED AND REMAINED WHEN SECURING THE RIGHT VENTRICULAR LEAD TO THE SUCTION SLEEVE. THE ATTENDING PHYSICIAN VERIFIED THE DETACHED COMPONENT TO BE SIMILAR WITH THE TRANSLUCENT RING SHAPED PART FROM A NEW GUIDE CATHETER. THE INVOLVED RV LEAD DID NOT EXHIBIT LEAD DISLODGEMENT WITH NORMAL LEAD DATA MEASUREMENTS AS REPEATEDLY CHECKED WITH NO SIGNIFICANT CHANGES. THIS ACCESSORY WAS OUT OF SERVICE AND WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134876 DELIVERY CATHETER SSPC3 CATHETER, PERCUTANEOUS DQY CENTERPOINT SYSTEMS 9183 CL14176 00810024671830

    Patients

    Seq Age Sex Outcome Treatment
    1