BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY

    MDR report key: 2011862 · Received March 9, 2011

    Report

    Report Number
    2029046-2011-00017
    Event Type
    Death
    Date Received
    March 9, 2011
    Date of Event
    December 27, 2010
    Report Date
    February 14, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION. BWI CONCOMITANT PRODUCTS: CARTO RMT SYSTEM; US CAT NUM M573001, SERIAL NUMBER: (B)(6). WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY: US CAT NUM EZ STEER CORONARY SINUS, LOT NUMBER UNKNOWN. SOUNDSTAR CATHETER: US CAT NUM SNDSTR10, LOT NUMBER UNKNOWN. EZ STEER THERMOCOOL NAV BI-DIRECTIONAL: US CAT NUM BNI75TCFJH, LOT NUMBER UNKNOWN. OTHER CONCOMITANT PRODUCTS: ST. JUDE'S AGILIS STEERABLE SHEATH; ST. JUDE'S BROCKENBROUGH NEEDLE. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, BWI RECEIVED A FINAL AUTOPSY REPORT FROM THE OFFICE OF THE MEDICAL INVESTIGATOR. NOTE: COPY OF THE FINAL AUTOPSY REPORT WAS SENT TO THE FDA AS REQUESTED UNDER MEDWATCH 3500A REPORT #2029046-2011-00016 ON SUPPLEMENTAL #2 ELECTRONICALLY SUBMITTED ON (B)(6) 2011. BIOSENSE WEBSTER MANUFACTURER'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT DEATH ON (B)(6) 2010. PATIENT UNDERWENT PVI ABLATION ON (B)(6) 2010. ACCORDING TO THE PHYSICIAN, THE PROCEDURE WENT REASONABLY WELL WITHOUT APPARENT PROBLEMS. THE PHYSICIAN ALSO MENTIONED THAT THE NUMBER OF LESIONS WERE LARGE AND THE OVERALL DURATION OF ABLATIONS WERE LONG. THE PROCEDURE WAS COMPLETED, AND AF WAS TERMINATED WITH CARDIOVERSION. PATIENT DID NOT HAVE ANY SIGNIFICANT SYMPTOMS DURING OR IMMEDIATELY AFTER THE PROCEDURE. PATIENT'S VENTRICULAR FUNCTION WAS NORMALIZED AND PATIENT RETURNED TO EXERCISE AFTER THE PROCEDURE. PER THE PHYSICIAN, "NOTHING MAJOR OBSERVED. I DID NOTICE SLIGHT CHARRING AT THE FIRST RING OF RMT THERMOCOOL CATHETER, BUT DID NOT THINK THAT WAS ANYTHING MAJOR OR WORTH OF CONCERN. I WAS CAREFUL WITH OBSERVATIONS LIKE CHARRING, AND I WOULD INFORM PATIENT'S FAMILY MEMBERS IF I SEE ANYTHING OF CONCERN. IN THIS CASE, IT WAS REALLY MINOR. HAD IT BEEN ANYTHING OF A CONCERN, I WOULD HAVE INFORMED THE PATIENT'S FAMILY. ON (B)(6) 2010, PATIENT CAME TO US WITH FEVER AND STROKE-LIKE SYMPTOMS, AND WAS TREATED ACCORDINGLY. THE AUTOPSY LATER DID NOT SHOW ANY STROKES, INSTEAD SHOWED FOREIGN PARTICLES IN MULTIPLE ORGANS, GRANULAR SHAPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1266-01-S UNKNOWN_D-1266-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death