BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER? OPEN-IRRIGATED

    MDR report key: 4948351 · Received July 28, 2015

    Report

    Report Number
    2134265-2015-04719
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Report Date
    June 30, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HAS A KINK AT 8.5CM FROM THE TIP WHILE IN THE NEUTRAL POSITION. IN ADDITION THE RING 3 HAS BROKEN ADHESIVE AND FLUIDS UNDER IT. 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 ANALYSIS COMPLETED ON (B)(4) 2015. IT WAS REPORTED THAT A SHAFT KINK OCCURRED. A 7.5X110X2.5 OPEN IRRIGATED QUAD LGR WAS SELECTED TO TREAT THE TARGET LESION. DURING THE PROCEDURE, IT WAS NOTED THAT IRRIGATION HUB TUBING OF THE CATHETER IS UNUSUALLY FLEXIBLE AND KINKS VERY EASILY WHEN MANEUVERING THE CATHETER. THERE WERE NO PATIENT WERE COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED BROKEN ADHESIVE AT RING# 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490554 BLAZER? OPEN-IRRIGATED CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE M004EPT9620K20 17257924

    Patients

    Seq Age Sex Outcome Treatment
    1