BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER¿ II XP

    MDR report key: 2760247 · Received September 26, 2012

    Report

    Report Number
    2134265-2012-05607
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THE DEVICE WAS WITHIN SPECIFICATIONS. NO ANOMALIES WERE NOTED NEAR THE TORQUE HOLE AND THE DEVICE WAS STEERED AND INSPECTED IN BOTH DIRECTIONS USING A POST STERILE TEMPLATE WITH NO ISSUES. THE DISTAL SECTION WAS ALSO INSPECTED FOR STRAIGHTNESS IN THE UN-STEERED (NEUTRAL) POSITION AND NO ISSUES WERE NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR#2134265-2012-05606. IT WAS REPORTED THAT DURING PREPARATION FOR A TREATMENT PROCEDURE, A CATHETER SHAFT IRREGULARITY WAS NOTED. THE 7/110/2.5/8-8 BLAZER XP DIAGNOSTIC CATHETER WAS SELECTED FOR RIGHT ATRIAL FLUTTER ABLATION BUT DURING PREPARATION, IT WAS NOTED THAT THERE WAS A CLEAR CRACK THROUGH THE OUTER INSULATION AT THE "PIN HOLE" JUST BELOW THE DISTAL TIP TRANSITION FROM MID SHAFT. THE 7/110/2.5/8-8 BLAZER XP DIAGNOSTIC CATHETER WAS SELECTED FOR RIGHT ATRIAL FLUTTER ABLATION BUT DURING PREPARATION, IT WAS NOTED THAT THERE WAS AN IRREGULARITY IN THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR#2134265-2012-05606. IT WAS REPORTED THAT DURING PREPARATION FOR A TREATMENT PROCEDURE, A CATHETER SHAFT IRREGULARITY WAS NOTED. THE 7/110/2.5/8-8 BLAZER XP DIAGNOSTIC CATHETER WAS SELECTED FOR RIGHT ATRIAL FLUTTER ABLATION BUT DURING PREPARATION, IT WAS NOTED THAT THERE WAS A CLEAR CRACK THROUGH THE OUTER INSULATION AT THE "PIN HOLE" JUST BELOW THE DISTAL TIP TRANSITION FROM MID SHAFT. THE 7/110/2.5/8-8 BLAZER XP DIAGNOSTIC CATHETER WAS SELECTED FOR RIGHT ATRIAL FLUTTER ABLATION BUT DURING PREPARATION, IT WAS NOTED THAT THERE WAS AN IRREGULARITY IN THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER¿ II XP CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M004EPT4500THK20 0015341502

    Patients

    Seq Age Sex Outcome Treatment
    1