BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3929389 · Received July 11, 2014

    Report

    Report Number
    9673241-2014-00256
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 17, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INCORRECTLY STATED THAT THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED ON THE INITIAL MEDWATCH # 9673241-2014-00256 (BRAND NAME: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER / US CATALOG # D133604IL) WAS TREATED AS MARKETED IN USA OR APPROVED BY THE FDA, WHILE IN FACT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. THEREFORE, THIS IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER 510(K) P030031/ PMA # S053. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE THE LOT # 16072635M WAS PROVIDED, THE DEVICE HISTORY RECORD(S) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE DATE OF DEATH IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    IN THE 3500A IT WAS REPORTED THAT THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS POSSIBLY DEVICE RELATED BUT NOT DUE TO ANY MALFUNCTION OF BWI PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 19, 2015 STATING THAT THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS UNRELATED TO THE PROCEDURE OR DEVICE. ALSO, SUBMITTING A CORRECTION TO THE SPELLING OF THE ACCOUNT. ORIGINALLY, SUBMITTED ON THE 3500A THAT THE ACCOUNT NAME WAS (B)(6) HOSPITAL. IT SHOULD BE (B)(6) HOSPITAL. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT, (B)(6), UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE AND DURING THE PROCEDURE LOST CONSCIOUSNESS AND SINK INTO A COMA, AFTERWARD, DECEASED. THE PATIENT HAD PERSISTENT ATRIAL FIBRILLATION. AFTER COMPLETING PULMONARY VEIN ISOLATION, THE PHYISICIAN PERFORMED AN ELECTRICAL CARDIOVERSION.THE PATIENT LOST CONSCIOUSNESS AND SINK INTO A COMA. THE PHYSICIAN INSTALLED A TEMPORARY PACEMAKER AND PERFORMED A CARDIOPULMONARY RESUSCITATION (CPR) IMMEDIATELY. THE PATIENT WAS UNSTABLE AND SENT TO THE INTESIVE CARE UNIT (ICU) FOR FURTHER TREATMENT. THE PATIENT EXPIRED. THE CAUSE OF DEAH IS UNKNOWN. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS POSSIBLE DEVICE RELATED BUT NOT DUE TO ANY MALFUNCTION OF BWI PRODUCTS. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406401 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-04IL-S UNKNOWN_D-1336-04IL-S

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death