BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 14954037 · Received July 8, 2022

    Report

    Report Number
    2029046-2022-01555
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 8, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YANG ZAIXIN, SHI LIANG, WANG YANJIANG, ET AL. SAFETY OF ACTIVATED CLOTTING TIME MAINTAINED AT 220 ~ 270 S DURING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION [J]. CLINICAL CARDIOVASCULAR. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    "THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YANG ZAIXIN, SHI LIANG, WANG YANJIANG, ET AL. SAFETY OF ACTIVATED CLOTTING TIME MAINTAINED AT 220 ~ 270 S DURING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION [J]. CLINICAL CARDIOVASCULAR OBJECTIVE/METHODS/STUDY DATA: TO ASSESS THE SAFETY OF MAINTAINING ACTIVATED CLOTTING TIME (ACT) SLIGHTLY BELOW GUIDELINE RECOMMENDATIONS DURING CATHETER ABLATION IN PATIENTS WITH ATRIAL FIBRILLATION (AF). METHODS: ONE HUNDRED AND SIXTY-FIVE CONSECUTIVE PATIENTS UNDERGOING RADIOFREQUENCY CATHETER ABLATION FOR ATRIAL FIBRILLATION WERE ENROLLED. AFTER SUCCESSFUL ATRIAL SEPTAL PUNCTURE, THE FIRST DOSE OF HEPARIN WAS 100 U/KG ACCORDING TO BODY WEIGHT, AND THEN ACT WAS MEASURED EVERY 15 ~ 20 MIN. 1000 ~ 2000 U HEPARIN WAS ADDED EACH TIME ACCORDING TO ACT VALUES, AND THE TARGET RANGE OF ACT WAS 220 ~ 270 S. PULMONARY VEIN ISOLATION AND LEFT ATRIAL ABLATION WERE PERFORMED USING A COLD SALINE-IRRIGATED ABLATION CATHETER. RESULTS: THE MEAN INTRAOPERATIVE ACT WAS (234.6 ± 30.4) S, THE MEAN OPERATION TIME WAS (145.8 ± 36.7) MIN, AND THE MEAN INTRAOPERATIVE HEPARIN DOSAGE WAS (11092.0 ± 2297.6) U. IN TERMS OF COMPLICATIONS, SYMPTOMATIC CEREBRAL EMBOLISM OCCURRED IN 1 PATIENT (0.09%) AND ACUTE CARDIAC TAMPONADE OCCURRED IN 10 PATIENTS (0.9%). CONCLUSION: UNDER THE CONDITION OF TRANSSEPTAL PUNCTURE AND COLD SALINE-IRRIGATED ABLATION CATHETER, MAINTAINING THE MEAN ACT VALUE BELOW THE RANGE RECOMMENDED BY THE GUIDELINES DURING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION DOES NOT INCREASE THROMBOEMBOLIC EVENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTOUCH DIAGNOSTIC/ABLATION DEFLECTABLE TIP SALINE IRRIGATION ABLATION CATHETER OTHER BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 SYSTEM, PENTARAY MULTI-ELECTRODE CATHETER. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A . ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: COMPLICATIONS OCCURRED IN 11 PATIENTS. 1. SYMPTOMATIC CEREBRAL EMBOLISM IN 1 PATIENT - THE PATIENT DEVELOPED BLURRED VISION IN THE RIGHT EYE IMMEDIATELY AFTER SURGERY, WITH DOUBLE VISION. CRANIAL MAGNETIC RESONANCE IMAGING REVEALED A NEW INFARCT IN THE RIGHT THALAMUS. ORAL DABIGATRAN 150 MG TWICE A DAY WAS USED FOR ANTICOAGULANT THERAPY, AND THE SYMPTOMS IMPROVED. 2. THERE WERE 10 CASES (0.9%) OF INTRAOPERATIVE ACUTE CARDIAC TAMPONADE, WITH AN AVERAGE ACT OF (247.8 ± 89.3) S, OF WHICH 9 CASES(0.8%) WERE IMPROVED AND DISCHARGED AFTER PERICARDIOCENTESIS DRAINAGE TREATMENT; 1 CASE (0.09%) OF CARDIAC TAMPONADE WAS IMPROVED AND DISCHARGED AFTER EMERGENCY THORACIC THORACOTOMY REPAIR, WITH AN AVERAGE ACT OF 481.9 S DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851076 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L CARTO 3 SYSTEM.| PENTARAY MULTI-ELECTRODE CATHETER.