BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8491632 · Received April 8, 2019

    Report

    Report Number
    2029046-2019-02957
    Event Type
    Injury
    Date Received
    April 8, 2019
    Date of Event
    March 14, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 77-YEAR-OLD FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. ADDITIONAL INFORMATION WAS RECEIVED 7/3/2019, INDICATING 76 APPLICATIONS OF RADIO FREQUENCY WAS DELIVERED FROM THE THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER. ON POST-PROCEDURE DAY 11 ((B)(6) 2019) THE PATIENT DEVELOPED BILATERAL PLEURAL EFFUSION. NO DEVICE DEFICIENCY WAS REPORTED. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. ISSUE WAS RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT RELATED TO THE STUDY DEVICE (VISITAG SURPOINT EXTERNAL PROCESSING UNIT), NOT RELATED TO THE STUDY CATHETER, NOT RELATED TO THE BIOSENSE WEBSTER INC. NON-INVESTIGATIONAL DEVICE AND CAUSAL INDEX PROCEDURE RELATED. MANUFACTURE REF NO: (B)(4).

    Additional Manufacturer Narrative · 0

    ON(B)(6)2020 , BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION INDICATING THE PATIENT HAD ¿RECOVERED¿ FROM THE ADVERSE EVENT OF CARDIAC TAMPONADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. CORRECTION: IT WAS NOTICED THAT THE CONCOMITANT PRODUCTS WERE INADVERTENTLY OMITTED FROM PREVIOUSLY REPORTED MEDWATCH REPORTS. THE FOLLOWING ITEMS HAVE NOW BEEN ADDED TO SECTION D11. CONCOMITANT MED. PRODUCTS: VISITAG SURPOINT EXTERNAL PROCESSING UNIT (EPU), SMARTABLATE GENERATOR KIT-WW, THERMOCOOL SMARTTOUCHSF/ST INTERFACE CABLE, CARTO 3 V6.0 SYSTEM, CARTO EXTERNAL REFERENCE PATCHES, SMARTABLATE IRRIGATION PUMP. CORRECTION: IT WAS NOTICED THE H6. PATIENT CODE OF 2010 ¿PLEURAL EFFUSION¿ WAS INADVERTENTLY OMITTED FROM THE SUPPLEMENTAL MDR # 2. IT HAS NOW BEEN ADDED. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 77-YEAR-OLD FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IN THE INITIAL REPORT, THE MANUFACTURE ADDRESS WAS ERRONEOUSLY REPORTED AS 31 TECHNOLOGY DR. IRVINE, CA 92618. THE CORRECT ADDRESS IS 33 TECHNOLOGY DR. IRVINE, CA 92618. SECTION D3 OF THIS REPORT HAS BEEN UPDATED. ON 4/8/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. MANUFACTURER REF NO:(B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED; THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. CONCOMITANT PRODUCTS: VISITAG SURPOINT EPU (MODEL# D160801, SERIAL# (B)(4)). MANUFACTURE REF NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMART TOUCH SF BIDIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AT AN UNSPECIFIED POINT, CARDIAC TAMPONADE WAS CONFIRMED. AN UNSPECIFIED MEDICATION WAS ADMINISTERED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. ISSUE IS RECOVERING. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS MILD IN SEVERITY, SERIOUS, NOT RELATED TO THE STUDY DEVICE (VISITAG SURPOINY EPU), CAUSAL RELATED TO THE STUDY CATHETERS, NOT RELATED TO THE BIOSENSE WEBSTER INC. (BWI) NON-INVESTIGATIONAL DEVICE AND CAUSAL INDEX PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284222 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134804 30159960L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R CARTO 3 SYSTEM| CARTO3 EXTERNAL REFPATCH 6PACK| CBL, 34 HYP/34 LEMO, 10'| SEE H10 SECTION| SMARTABLATE GENERATOR KIT-WW| SMARTABLATE PUMP KIT-WW| VISITAG SURPOINT EPU