BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 21120797 · Received January 9, 2025

    Report

    Report Number
    2029046-2025-00105
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    December 10, 2024
    Report Date
    February 28, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31064979M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2025. THE PATIENT WAS OVER 75 YEARS OLD WITH PERSISTENT ATRIAL FIBRILLATION. NO HISTORY OF PREVIOUS STROKE. SHE WAS IN ORAL ANTICOAGULANTS(OAC) BEFORE AND AFTER PROCEDURE UNDERWENT OAC AGAIN. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED STROKE. PATIENT WAS CHECKED FOR PRE-THROMBUS CLOT BEFORE ABLATION. HOWEVER, THERE WERE CONCERNS THAT THERE COULD BE SOME PRE-EXISTING CLOT. HOWEVER, THE PHYSICIAN DECIDED TO PROCEED. PATIENT WAS NOTED TO HAVE A VERY LARGE ATRIUM, HIGHLY SCARRED AND FIBROTIC. DURING THE ABLATION: ABLATED WHILE IN ATRIAL FIBRILLATION (AF), AF DID CONVERT TO ATRIAL TACHYCARDIA (AT) AND THEN SINUS DURING ABLATION. NO CARDIOVERSION WAS DONE. 57 VARIPULSETM CATHETER ABLATIONS WERE PERFORMED. A MINIMUM OF 6 CATHETER EXCHANGES WERE PERFORMED (HIGH NUMBER OF CATHETER EXCHANGES). FIXED SHEATH FOR TRANSSEPTAL PUNCTURE (TS); VIZIGO FOR VARIPULSETM CATHETER. THE FOLLOWING WAS NOTED ABOUT THE CASE THAT PRESENTED RISKS: HIGH NUMBER OF ABLATION DELIVERIES BOTH WITH VARIPULSETM CATHETER AND WITH THE GALAXY PFA SYSTEM TO PROVIDE EXTENSIVE ABLATION. PSAF PATIENT TREATED IN AFIB, OUR INDICATIONS ARE FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF) PATIENTS, AND THE CONCERN OF CLOT PRE-ABLATION, BUT CASE CONTINUED. PULMONARY VEIN ISOLATION (PVI) + POSTSYSTOLIC THICKENING (PST) WALL PERFORMED WITH VARIPULSETM CATHETER. MITRAL LINE + ANT WALL PERFORMED WITH GALAXY ST. PATIENT EXPERIENCED LEFT LEG PARALYSIS AND AFTER FEW DAYS RECOVERED. THEREFORE, UPDATED "B6. TESTS/LAB DATA INCLUDING DATES" AND "D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES" FIELDS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 04-FEB-2025. THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD A STROKE. THE PATIENT EXPERIENCED LEFT LEG PARALYSIS AND AFTER FEW DAYS RECOVERED. THEY DID COMPUTED TOMOGRAPHY (CT) SCAN TO EXCLUDE THROMBUS IN LEFT ATRIAL APPENDAGE (LAA). IT WAS ASSESS AS FREE; HOWEVER, IT HAS BEEN REPORTED THAT IMAGES WERE NOT CLEAR AT ALL AND SOME DOUBTS /DISCUSSION HAPPENED BEFORE DECIDING IF TO MOVE FORWARD OR NOT. LOOKS LIKE SOME PECTINATED MUSCLES GENERATED SOME DOUBTS. THEY DID THE TRANSSEPTAL WITH FIXED SHEATH AND THEN SWITCHED TO DEFLECTABLE SHEATH. THEY DID THE PROCEDURE IN AF: ATRIUM WAS VERY DILATED AND SCARRED. ABLATION STRATEGY: PULMONARY VEIN ISOLATION (PVI) + PST WALL PERFORMED WITH VARIPULSETM CATHETER. MITRAL LINE + ANT WALL PERFORMED WITH GALAXY ST. SHE STARTED IN ATRIAL FIBRILLATION, THEN SHE WENT IN ATRIAL TACHYCARDIA (AT) SO THEY MAPPED THE AT USING OPTRELL. THEN THEY ALSO SWITCHED TO GALAXY WITH THERMOCOOL SMARTTOUCH CATHETER, BUT AGAIN SWITCHING TO THERAPEUTIC CATHETER AND HE ADMITTED SOME CATHETER EXCHANGES (AT LEAST 6). SHE FINALLY GOT SINUS RHYTHM. THEREFORE, UPDATED SECTION "D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES". IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A VARIPULSETM CATHETER AND THERMOCOOL SMARTTOUCH CATHETER IN WHICH THE PATIENT EXPERIENCED A STROKE. A PATIENT WAS SUBMITTED TO AFIB ABLATION PROCEDURE THAT WAS PERFORMED WITH VARIPULSETM CATHETER AND THERMOCOOL SMARTTOUCH CATHETER (WITH PFA ENERGY DELIVERY THROUGH GALAXY SYSTEM GENERATOR, CARDIOFOCUS). PROCEDURE WAS COMPLETED WITHOUT ANY OCCURRENCE. PHYSICIAN REPORTED THAT THE DAY AFTER THE PROCEDURE, THE PATIENT SUFFERED A STROKE THAT WAS CONFIRMED BY THE NEUROLOGY SERVICE. PATIENT HAD A COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI). ADDITIONAL INFORMATION WAS RECEIVED ON 27-DEC-2024. THE PROCEDURE INCLUDED PULMONARY VEIN ISOLATION, LEFT ATRIUM (LA) POSTERIOR WALL ISOLATION, MITRAL ISTHMUS ABLATION, AND FRAGMENTED POTENTIAL IN LA ANTERIOR WALL. PROCEDURAL ACT WAS >350. ULTRASOUND NOT USED DURING PROCEDURE AND NO OTHER ERRORS WAS OBSERVED. THERE WAS NO EVIDENCE OF CHAR / THROMBUS / CLOT DURING THE PROCEDURE. PATIENT IMPROVED; HOWEVER, REQUIRED EXTENDED HOSPITALIZATION. THE PATIENT'S SYMPTOMS RESOLVED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PATIENT CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 06-JAN-2025. THE HOSPITALIZATION WAS FOR MONITORING PURPOSES AND FOR PERFORMING COMPLEMENTARY DIAGNOSTIC METHODS. ADDITIONAL INFORMATION WAS RECEIVED ON 07-JAN-2025. PATIENT SHOWED AFTER 1-2 DAYS AFTER THE PROCEDURE CLEAR SYMPTOMS OF STROKE SO WENT BACK TO THE HOSPITAL TO CONFIRM WITH NEUROLOGIST. CT SCAN WAS DONE BEFORE THE PROCEDURE TO EXCLUDE THROMBUS. THE PATIENT HAD A VERY EXTENSIVE ABLATION. THE PATIENT WAS IN PERSISTENT ATRIAL FIBRILLATION (PSAF), SO THEY ABLATED PULMONARY VEIN ISOLATION (PVI) + POSTSYSTOLIC THICKENING (PST) WALL + MITRAL ISTHMUS (MI) WITH VARIPULSETM CATHETER AND TRUPULSE. ONCE THEY FINISHED WITH VARIPULSETM CATHETER, THEY SWITCHED TO GALAXY AND THERMOCOOL SMARTTOUCH CATHETER AND THEY ABLATED THE ANTERIOR LINE. NO RF NOR GALAXY SYSTEM GENERATOR WAS CONNECTED DURING VARIPULSETM CATHETER ABLATION. THE PATIENT DID NOT EVEN HAVE AN INDIFFERENT ELECTRODE ATTACHED. PHYSICIAN SAID IT WAS PROCEDURE RELATED. HE DOES NOT KNOW IF IT WAS DUE TO THE VARIPULSETM CATHETER OR GALAXY. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE VARIPULSETM CATHETER AND THERMOCOOL SMARTTOUCH CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583294 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31064979M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Life Threatening| R 8.5 FR VARIPULSE CATHETER.| GALAXY SYSTEM GENERATOR, CARDIOFOCUS.| NGEN PUMP, EU CONFIGURATION.| TRUPULSE GENERATOR, WW.| UNK DEFLECTABLE SHEATH.| UNK_CARTO 3.| UNK_CARTO VIZIGO SHEATH.| UNK_OPTRELL MAPPING CATHETER.