BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER PRIME XP TEMPERATURE ABLATION CATHETER

    MDR report key: 24716156 · Received March 30, 2026

    Report

    Report Number
    2124215-2026-16969
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OAD
    UDI-DI
    08714729786368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BLOCKS B5, E1 (INITIAL REPORTER TITLE, FIRST NAME, LAST NAME, FACILITY NAME, ADDRESS 1, CITY, ZIP/POST CODE, PHONE, EMAIL), E2, AND E3 HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION RECEIVED ON MARCH 30, 2026.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS USED IN THE SAME PROCEDURE. IT WAS REPORTED THAT THE CATHETER TEMPERATURE READING REMAINED UNCHANGED. DURING A CAVO-TRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE, A BLAZER PRIME XP TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE. UPON CONNECTION TO THE GENERATOR, THE TEMPERATURE DISPLAYED 21 DEGREES CELSIUS AND CONTINUED TO DISPLAY THIS TEMPERATURE THROUGHOUT PREPARATION STEPS. AFTER INSERTION INSIDE THE PATIENT AND FIRST APPLICATION, THE TEMPERATURE READING REMAINED UNCHANGED. THE ADAPTOR CABLES WERE REPLACED, BUT THE PROBLEM WAS NOT RESOLVED. A SECOND BLAZER PRIME XP TEMPERATURE ABLATION CATHETER WAS THEN USED, WHICH DISPLAYED A TEMPERATURE OF 22 DEGREES CELSIUS, BUT ALSO REMAINED UNCHANGED. A THIRD BLAZER PRIME XP TEMPERATURE ABLATION CATHETER WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS USED IN THE SAME PROCEDURE. IT WAS REPORTED THAT THE CATHETER TEMPERATURE READING REMAINED UNCHANGED. DURING A CAVO-TRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE, A BLAZER PRIME XP TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE. UPON CONNECTION TO THE GENERATOR, THE TEMPERATURE DISPLAYED 21 DEGREES CELSIUS AND CONTINUED TO DISPLAY THIS TEMPERATURE THROUGHOUT PREPARATION STEPS. AFTER INSERTION INSIDE THE PATIENT AND FIRST APPLICATION, THE TEMPERATURE READING REMAINED UNCHANGED. THE ADAPTOR CABLES WERE REPLACED, BUT THE PROBLEM WAS NOT RESOLVED. A SECOND BLAZER PRIME XP TEMPERATURE ABLATION CATHETER WAS THEN USED, WHICH DISPLAYED A TEMPERATURE OF 22 DEGREES CELSIUS, BUT ALSO REMAINED UNCHANGED. A THIRD BLAZER PRIME XP TEMPERATURE ABLATION CATHETER WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RECEIVED, PENDING ANALYSIS. ADDITIONAL INFORMATION RECEIVED ON MARCH 30, 2026: NO ERROR MESSAGES WERE DISPLAYED. FOLLOWING CONNECTION, THE CATHETER TEMPERATURE SHOWED UP AT 21 DEGREES CELSIUS AND BECAME STUCK DESPITE CHANGES MADE DURING OR AFTER RADIOFREQUENCY (RF) APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345053 BLAZER PRIME XP TEMPERATURE ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC CORPORATION 87141 0036191682 08714729786368

    Patients

    Seq Age Sex Outcome Treatment
    1