BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER? OPEN-IRRIGATED

    MDR report key: 3062976 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02379
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: AS RECEIVED, THE CABLE WAS RECEIVED IN A BOX, COILED INSIDE A DOUBLED PLASTIC BAG. VISUAL INSPECTION FOUND NO BLOOD ON THE CATHETER. THE CATHETER'S ELECTRICAL CONNECTOR VERIFIED NORMAL DURING VISUAL INSPECTION. ALL ELECTRODE RESISTANCE VALUES WERE WITHIN SPECIFICATIONS. NO ELECTRICAL OPENS OR SHORTS WERE FOUND. THE THERMOCOUPLE READING WAS WITHIN SPECIFICATION. THE CATHETER PASSED THERMOCOUPLE RESPONSE TESTING. THE CATHETER PASSED RF ABLATION TESTING AND MET ALL SPECIFICATIONS DURING FLOW RATE TESTING. INSPECTION AND TESTING OF THE RETURNED CATHETER FOUND NO NONCONFORMANCE OR DEFECT THAT COULD HAVE CAUSED THE COMPLAINT EVENT. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER 50 YEARS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY ABLATION PROCEDURE, STEAM POPS OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY ONLY NO TRANS SEPTAL. DURING TREATMENT OF THE ATRIAL FLUTTER IN THE RIGHT ATRIUM THE PHYSICIAN PLACED A 7.5 110 2.5 BLAZER OPEN-IRRIGATED ABLATION CATHETER IN THE ON THE TRICUSPID ISTHMUS. THE PHYSICIAN WAS DOING THIRTY SECOND BURNS WITH POWER SET AT 35W AND A FLOW RATE OF 17ML WHEN TWO STEAM POPS OCCURRED AND THE CATHETER JUMPED. NO CHAR OR COAGULUM WAS OBSERVED ON ANY OF THE DEVICES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY ABLATION PROCEDURE, STEAM POPS OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY ONLY NO TRANS SEPTAL. DURING TREATMENT OF THE ATRIAL FLUTTER IN THE RIGHT ATRIUM THE PHYSICIAN PLACED A 7.5 110 2.5 BLAZER OPEN-IRRIGATED ABLATION CATHETER IN THE ON THE TRICUSPID ISTHMUS. THE PHYSICIAN WAS DOING THIRTY SECOND BURNS WITH POWER SET AT 35W AND A FLOW RATE OF 17ML WHEN TWO STEAM POPS OCCURRED AND THE CATHETER JUMPED. NO CHAR OR COAGULUM WAS OBSERVED ON ANY OF THE DEVICES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164174 BLAZER? OPEN-IRRIGATED CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE M004EPT9620K20 15047010

    Patients

    Seq Age Sex Outcome Treatment
    1