BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER PRIME® XP

    MDR report key: 3950314 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04250
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR EVALUATION. DEVICE ANALYSIS NOTED THAT A BROKEN ADHESIVE ON RING #1. THE ABLATION WAS VERIFIED BY USING A MAESTRO GENERATOR AND THE DEVICE WAS FOUND WITHIN SPECIFICATIONS. AN ELECTRICAL TEST WAS PERFORMED AND THE DEVICE WAS WITHIN SPECIFICATIONS AND NO OPENS OR SHORTS WERE FOUND. THE DEVICE WAS DISSECTED FINDING NO EVIDENCE OF BLOOD OR ANY FLUID INSIDE THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT THE NOISE WAS OBSERVED FROM THE CATHETER. A 7-110-2.5-8-8 VM K2 BLAZER PRIME® XP WAS USED TO TREAT ATRIAL FLUTTER. DURING THE CAVOTRICUSPID ISTHMUS (CTI) PROCEDURE, NOISE WAS OBSERVED FROM THE ABLATION CATHETER. A RE STERILIZED CABLE AND A DIFFERENT CONNECTING PORT WERE RECONNECTED BUT THE ISSUE WAS NOT RESOLVED. THE BLAZER CATHETER WAS EXCHANGED WITH ANOTHER OF THE SAME DEVICE BUT THE ISSUE WAS STILL NOT RESOLVED. THE CATHETER WAS REPLACED WITH A NON BSC DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED BROKEN ADHESIVE ON RING #1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428716 BLAZER PRIME® XP CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M004P4770THK20 16687506

    Patients

    Seq Age Sex Outcome Treatment
    1 BLAZER PRIME XP -CATHETER