BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4636978 · Received March 26, 2015

    Report

    Report Number
    2029046-2015-00065
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    December 1, 2011
    Report Date
    March 4, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCT: OTHER BWI PRODUCTS WERE USED DURING THIS PROCEDURE: CARTO AND LASSO. BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT AFTER AFIB PROCEDURE THE PATIENT HAD EXPERIENCED HEMOTHORAX FROM SUB- CLAVIAN VEIN BLEEDING. BASED ON THE NARRATIVE, THERE WERE NO COMPLAINTS REPORTED RELATED TO CATHETER MALFUNCTION IMMEDIATELY AFTER THE PROCEDURE WHICH MIGHT SUGGEST THAT THE COMPLICATION WAS PROCEDURE RELATED AND NOT A MALFUNCTION OF BWI PRODUCT. TITLE: SINUS RHYTHM RESTORATION AND ARRHYTHMIA NONINDUCIBILITY ARE MAJOR PREDICTORS OF ARRHYTHMIA-FREE OUT COME AFTER ABLATION FOR LONG-STANDING PERSISTENT ATRIAL FIBRILLATION: A PROSPECTIVE STUDY. OBJECTIVES: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE PROGNOSTIC VALUE OF SINUS RHYTHM RESTORATION AT THE INITIAL PROCEDURE AND ARRHYTHMIA NONINDUCIBILITY AT THE FINAL REPEAT PROCEDURE FOR LONG- TERM OUTCOME. THIS SINGLE-CENTER STUDY ANALYZED A PROSPECTIVE REGISTRY OF ALL 203 CONSECUTIVE PATIENTS WHO UNDERWENT THEIR FIRST AF ABLATION BETWEEN JULY 2006 AND DECEMBER 2011. OTHER ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE: -2 PATIENTS HAD EXPERIENCED TRANSIENT ISCHEMIC ATTACK; -1 PATIENT HAD EXPERIENCED CARDIAC TAMPONADE FROM STEAMPOP; -1 PATIENT HAD EXPERIENCED TRANSITORY FEMORAL NEURAPRAXIA. THERE ARE NO DEATH EVENTS AND DEVICE MALFUNCTIONS REPORTED IN THE PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THE NAVISTAR THERMOCOOL. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203188 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1197-00 UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other