BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER® II

    MDR report key: 3931181 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04172
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    LPB
    PMA / PMN Number
    P920047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. DURING VISUAL EXAMINATION, IT WAS NOTED THAT THE DEVICE IS SEVERELY DAMAGED AT THE DISTAL SECTION. THE SHAFT IS TORN/SPLIT AT 4CM FROM THE TIP, AND THERE IS BLOOD RESIDUE INSIDE THE DEVICE. ALSO, THE TIP HAS SEVERAL RIPS, THE ADHESIVE IS LIFTED AND BROKEN IN ALL RINGS, AND THERE ARE CHARS IN ALL THE RINGS. 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CURVE OF THE CATHETER HAD A CRACKED COATING. THE TARGET LESION WAS LOCATED IN THE LEFT SIDE OF THE HEART. A 7/110/4/2.5/8-5 BLAZER II WAS SELECTED TO TREAT THE TARGET LESION. DURING PROCEDURE, THE CATHETER DEFLECTED PROPERLY AND WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THAT THE CATHETER COATING SEEMED TO HAVE A CRACKED AT THE CURVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CURVE OF THE CATHETER HAD A CRACKED COATING. THE TARGET LESION WAS LOCATED IN THE LEFT SIDE OF THE HEART. A 7/110/4/2.5/8-5 BLAZERI WAS SELECTED TO TREAT THE TARGET LESION. DURING PROCEDURE, THE CATHETER DEFLECTED PROPERLY AND WHEN THE CATHETER WAS REMOVED, IT WAS NOTED THAT THE CATHETER COATING SEEMED TO HAVE A CRACKED AT THE CURVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410742 BLAZER® II CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M0045086T0 16722469

    Patients

    Seq Age Sex Outcome Treatment
    1