BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15325542 · Received August 30, 2022

    Report

    Report Number
    2029046-2022-02047
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 3, 2022
    Report Date
    September 23, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 69-YEAR-OLD MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING AN ATTEMPTED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. THE PATIENT SUFFERED A CARDIAC TAMPONADE DURING TRANSSEPTAL ACCESS. THE PHYSICIAN'S TECHNIQUE FOR TRANSSEPTAL ACCESS IS TO INSERT THE ABLATION CATHETER THEN SHEATH INTO THE SUPERIOR VENA CAVA (SVC), THEN WITHDRAW THE ABLATION CATHETER AND ALLOW THE SHEATH TO "DROP" TO THE INTERATRIAL SEPTUM. WHEN ATTEMPTING TRANSSEPTAL ACCESS, THE SHEATH WOULD DROP FROM THE SVC INTO THE RIGHT VENTRICLE- THIS OCCURRED SEVERAL TIMES. A CARDIAC TAMPONADE WAS THEN NOTED ON INTRACARDIAC ECHO (ICE) IMAGING, AND THE PATIENT BECAME HYPOTENSIVE. A PERICARDIOCENTESIS WAS ATTEMPTED, BUT IT WAS NOT SUCCESSFUL. THE PATIENT IS BEING CONSIDERED FOR CT SURGERY AT THIS TIME. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS IMPROVED AND THE PATIENT WAS TO BE DISCHARGED FROM HOSPITAL. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND AN EVALUATION OF ALL FEATURES OF THE DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT NO DAMAGE OR ANOMALIES ON THE DEVICE. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. THE MAGNETIC, ELECTRICAL, TEMPERATURE AND FORCE FEATURES WERE TESTED AND NO ISSUES WERE OBSERVED. IN ADDITION, THE PRODUCT WAS DEFLECTING AND IRRIGATING CORRECTLY. NO MALFUNCTIONS WERE OBSERVED DURING THE PRODUCT ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # PC-001174093 CORRECTIONS: ON 9/1/2022, IT WAS NOTICED THE "ABBOTT SWARTZ SLO SHEATH 63 CM" WAS INADVERTENTLY OMITTED FROM THE 3500A INITIAL MEDWATCH. IT HAS NOW BEEN ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 69-YEAR-OLD MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING AN ATTEMPTED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. THE PATIENT SUFFERED A CARDIAC TAMPONADE DURING TRANSSEPTAL ACCESS. THE PHYSICIAN'S TECHNIQUE FOR TRANSSEPTAL ACCESS IS TO INSERT THE ABLATION CATHETER THEN SHEATH INTO THE SUPERIOR VENA CAVA (SVC), THEN WITHDRAW THE ABLATION CATHETER AND ALLOW THE SHEATH TO "DROP" TO THE INTERATRIAL SEPTUM. WHEN ATTEMPTING TRANSSEPTAL ACCESS, THE SHEATH WOULD DROP FROM THE SVC INTO THE RIGHT VENTRICLE- THIS OCCURRED SEVERAL TIMES. A CARDIAC TAMPONADE WAS THEN NOTED ON INTRACARDIAC ECHO (ICE) IMAGING, AND THE PATIENT BECAME HYPOTENSIVE. A PERICARDIOCENTESIS WAS ATTEMPTED, BUT IT WAS NOT SUCCESSFUL. THE PATIENT IS BEING CONSIDERED FOR CT SURGERY AT THIS TIME. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BWI PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS A "HOLE IN RIGHT VENTRICLE". TRANSSEPTAL PUNCTURE WAS NOT PERFORMED BUT WAS ATTEMPTED WITH A BRK 1 NEEDLE. NO ABLATION WAS PERFORMED. THE EVENT OCCURRED DURING TRANSSEPTAL PHASE. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS A DIFFICULT PATIENT ANATOMY. THE PATIENT REQUIRED CT SURGERY. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS IMPROVED AND THE PATIENT WAS TO BE DISCHARGED FROM HOSPITAL ON (B)(6) 2022. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT FOR RECOVERY AND OBSERVATION AFTER CT SURGERY. A SMARTABLATE GENERATOR WAS USED IN THIS CASE. FORCE VISUALIZATION FEATURES USED WERE GRAPH & DASHBOARD. THIS EVENT WILL BE CONSERVATIVELY REPORTED AGAINST THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AS THE ISSUE OCCURRED IN THE AREA OF THE CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468887 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134804 30818345L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention| L ABBOTT SWARTZ SLO SHEATH 63 CM| BRK 1 NEEDLE| CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-US| UNK_SOUNDSTAR