BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER PRIME? XP

    MDR report key: 3882223 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03458
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    March 31, 2013
    Report Date
    May 21, 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

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RECEIVED FOR ANALYSIS. UNIT RETURNED IN A GENERIC PLASTIC BAG WHICH HAS A KINK AT THE DISTAL SECTION WHILE IN THE NEUTRAL POSITION. IN ADDITION IT WAS ALSO NOTED THAT THERE WAS CHAR AT THE TIP OF THE DEVICE, ADHESIVE LIFTED AND BLOOD EVIDENCE UNDER THE ADHESIVE IN THE RING 2. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014 IT WAS REPORTED THAT THE TIP OF THE CATHETER KINK. THE TARGET LESION WAS LOCATED IN THE ISTHMUS AREA. A BLAZER PRIME XP WAS USED DURING FLUTTER ABLATION. DURING PROCEDURE THE TIP OF THE CATHETER GOT KINK. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE. HOWEVER, THE DISTAL SECTION HAS CHAR IN THE TIP AND THE ADHESIVE LIFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358674 BLAZER PRIME? XP CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M004EPTP4500THN40 16281471

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR