BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3935086 · Received July 15, 2014

    Report

    Report Number
    2029046-2014-00199
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: THE CARTO 3 SYSTEM: (SERIAL # (B)(4), MODEL# M-4800-01). STOCKERT 70: (SERIAL # (B)(4), MODEL# M-5463-01). COOLFLOW PUMP: (SERIAL # (B)(4), MODEL# M-5491-02). SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER: (MODEL # M-5723-12). DECANAV¿ ELECTROPHYSIOLOGY CATHETER: (MODEL# D-1283-02-S, LOT NUMBER UNK). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT, (B)(6), FEMALE, UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. THE PATIENT HAD NO REPORTED MEDICAL HISTORY THAT CONTRIBUTED TO THE EVENT. DURING THE PROCEDURE, THE CARTO 3 MAPPING SYSTEM FROZE AS THE PHYSICIAN ATTEMPTED TO MAP THE LOCATION OF THE CATHETERS INSIDE OF THE HEART. TO TROUBLESHOOT THE SOFTWARE ISSUE, THE WORKSTATION WAS REBOOTED; THE CASE WAS REOPENED AND CONTINUED. THERE WAS A NOTICEABLE MAP SHIFT ERROR OF AT LEAST 10 MM THAT OCCURRED WHEN ATTEMPTING TO CREATE MAPS UTILIZING CARTOSOUND AND PASO SOFTWARE ON THE CARTO MAPPING SYSTEM. THE PHYSICIAN THEN NOTICED THAT THE PATIENT¿S BLOOD PRESSURE WAS DECREASING AND DIAGNOSED A PERICARDIAL EFFUSION USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND BELIEVES THAT ONE OF THE CATHETERS IN PLACE MUST HAVE CAUSED A PERFORATION. THE PROCEDURE WAS ABORTED. A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 150 ML OF FLUID AND A PIGTAIL CATHETER WAS PUT IN PLACE TO ALLOW DRAINAGE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS EVENT MAY BE DUE TO A DIAGNOSTIC MEDTRONIC MARINR QUAD CATHETER THAT WAS ALSO BEING USED DURING THE EVENT, AS HE BELIEVES IT MAY HAVE PERFORATED THE HEART. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND FOUND IN GOOD PHYSICAL CONDITION. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE CATHETER WAS ALSO EVALUATED FOR CARTO 3 AND THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND IT WAS PROPERLY VISUALIZED. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. THE DEVICE HISTORY RECORD (DHR) 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 CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS RESULTS USING MONTHLY COMPLAINT TREND REPORTING. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE NO CAPA ACTIVITY IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6) Y.O., FEMALE, UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS. THE PATIENT HAD NO REPORTED MEDICAL HISTORY THAT CONTRIBUTED TO THE EVENT. DURING THE PROCEDURE, THE CARTO 3 MAPPING SYSTEM FROZE AS THE PHYSICIAN ATTEMPTED TO MAP THE LOCATION OF THE CATHETERS INSIDE OF THE HEART. TO TROUBLESHOOT THE SOFTWARE ISSUE, THE WORKSTATION WAS REBOOTED; THE CASE WAS REOPENED AND CONTINUED. THERE WAS A NOTICEABLE MAP SHIFT ERROR OF AT LEAST 10 MM THAT OCCURRED WHEN ATTEMPTING TO CREATE MAPS UTILIZING CARTOSOUND AND PASO SOFTWARE ON THE CARTO MAPPING SYSTEM. THE PHYSICIAN THEN NOTICED THAT THE PATIENT¿S BLOOD PRESSURE WAS DECREASING AND DIAGNOSED A PERICARDIAL EFFUSION USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND BELIEVES THAT ONE OF THE CATHETERS IN PLACE MUST HAVE CAUSED A PERFORATION. THE PROCEDURE WAS ABORTED. A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 150 ML OF FLUID AND A PIGTAIL CATHETER WAS PUT IN PLACE TO ALLOW DRAINAGE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS EVENT MAY BE DUE TO A DIAGNOSTIC MEDTRONIC MARINR QUAD CATHETER THAT WAS ALSO BEING USED DURING THE EVENT, AS HE BELIEVES IT MAY HAVE PERFORATED THE HEART. NONETHELESS, PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE AND BWI IS REPORTING THIS EVENT UNDER BOTH THE COMPLAINT DEVICE, THE THERMOCOOL CATHETER (THIS REPORT), AND UNDER THE CARTO 3 SYSTEM (AS A SEPARATE REPORT). THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412291 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1327-04-S 16086430M

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| O| R