BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4292496 · Received December 2, 2014

    Report

    Report Number
    2029046-2014-00467
    Event Type
    Injury
    Date Received
    December 2, 2014
    Date of Event
    December 1, 2012
    Report Date
    November 4, 2014
    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: 4 MM CELSIUS CATHETER (MODEL# UNKNOWN LOT# UNKNOWN); CARTO (MODEL# UNKNOWN SERIAL# UNKNOWN); ACUNAV (MODEL# UNKNOWN LOT# UNKNOWN); ENSITE NAVX (ST JUDE MEDICAL, ST PAUL, MN). (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4). EVENT DESCRIPTION CONTINUATION: - 2 PATIENTS OUT OF 17 DIED WITHIN 7 DAYS AFTER THE PROCEDURE DUE TO RECURRENCE OF MYOCARDIAL INFARCTION WITH KNOWN MULTI-VESSEL CORONARY DISEASE NOT SUITABLE TO REVASCULARIZATION. - 1 PATIENT OUT OF 17 DIED WITHIN 7 DAYS AFTER THE PROCEDURE DUE TO PERFORATION OF TEMPORARY PACING LEAD INSERTED TWO DAYS AFTER ABLATION. - 1 PATIENT HAD PERICARDITIS. - 2 PATIENT HAD CARDIAC ARREST DURING THE PROCEDURE AND REQUIRED CPR. - 14 PATIENT HAD FEMORAL PSEUDOANEURYSM. - 5 PATIENTS HAD FEMORAL ATRIO-VENOUS FISTULA. - 3 PATIENTS HAD GROIN HEMATOMA, WHICH REQUIRED SURGICAL INTERVENTION. - 4 PATIENTS HAD GROIN HEMATOMA, WHERE 3 PATIENTS REQUIRED TRANSFUSION AND ONE PATIENT WAS TREATED CONSERVATIVELY.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM LITERATURE SOURCE: - 1 PATIENT HAD HEMOPERICARDIUM AND WAS TREATED CONSERVATIVELY. CARDIAC PERFORATION WERE RELATED TO MAPPING OR ABLATION WITHIN THE RV. ARTICLE TITLE: ¿COMPLICATIONS OF CATHETER ABLATION OF VENTRICULAR TACHYCARDIA: A SINGLE CENTER EXPERIENCE.¿ THE GOAL OF THIS STUDY WAS TO ANALYZE THE INCIDENCE AND PREDICTORS OF MAJOR COMPLICATIONS OF VT ABLATION PROCEDURES IN A HIGH-VOLUME, EXPERT CENTER. THE STUDY INCLUDED ALL CONSECUTIVE VT CATHETER ABLATION PROCEDURES PERFORMED BETWEEN AUGUST 2006 AND DECEMBER 2012. FROM THE REPORT THERE WERE: - 2 PATIENTS HAD CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS, AND PATIENTS RECOVERED WITHOUT SEQUELAE. CARDIAC PERFORATION WERE RELATED TO MAPPING OR ABLATION WITHIN THE RV. - 2 PATIENTS PRESENTED WITH CEREBROVASCULAR ACCIDENTS DURING LV MAPPING BEFORE ABLATION, RELATED PRESUMABLY EITHER TO UNRECOGNIZED LV THROMBUS OR DISLODGEMENT OF ATHEROSCLEROTIC PLAQUES IN THE AORTA. - 1 PATIENT HAD INTRA-PROCEDURAL TRANSIENT ISCHEMIC ATTACK AFTER ¿STEAM POP¿ WHINING LV. - 1 PATIENT HAD MAJOR SYSTEMIC EMBOLIZATION TO THE LOWER EXTREMITY OCCURRED THE DAY AFTER THE PROCEDURE. - 1 PATIENT HAD TRANSIENT ISCHEMIC ATTACK 5 DAYS AFTER THE ABLATION. - 7 PATIENTS HAD HEART BLOCK AV 3 DEGREE. IN TWO PATIENTS, AV BLOCK WAS INTENTIONALLY CREATED DURING REPEAT PROCEDURES AS THE RECURRENT VTS ORIGINATED FROM THE VICINITY OF THE PROXIMAL PART OF LEFT BUNDLE BRANCH. - TOTAL OF 17 DEATH EVENTS WERE REPORTED IN THIS ARTICLE WITHIN 30 DAYS POST-PROCEDURE. 5 PATIENTS OUT OF 17 DIED WITHIN 7 DAYS AFTER THE PROCEDURE. THESE 5 DEATH EVENTS WILL BE REPORTED SEPARATELY. - 2 PATIENTS OUT OF 17 DIED WITHIN 7 DAYS AFTER THE PROCEDURE DUE TO PROGRESSION OF HEART FAILURE WITH INTRACTABLE VTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778627 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 58 YR Life Threatening