BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16889371 · Received May 8, 2023

    Report

    Report Number
    2029046-2023-00977
    Event Type
    Death
    Date Received
    May 8, 2023
    Date of Event
    January 1, 2021
    Report Date
    May 8, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNK_SMART TOUCH BIDIRECTIONAL SF (7 DAY POST INDEX) EVENTS REPORTED UNDER MWR-27122021-0001103881 UNDER MRN 2029046-2022-00086 AND UNK_SMART TOUCH BIDIRECTIONAL SF (30 DAYS POST INDEX) EVENTS REPORTED UNDER MWR-27122021-0001103882 UNDER MRN 2029046-2022-00085. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO 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. 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 THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITIES (REG20_01 NESTCC TEST CASE 07 PHASE 2 STUDY). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH CATHETER AND THERMOCOOL SMARTTOUCH SF CATHETER. EXACT QUANTITIES OF PRODUCTS CANNOT BE ACCURATELY DETERMINED AS A PATIENT CAN EXPERIENCE MORE THAN ONE SIGN/SYMPTOM/HEALTH IMPACT. ADDITIONAL INFORMATION RECEIVED ON 14-APR-2023 FOR RESULTS OF 90 DAY FROM INDEX ABLATION. ACCURATE NUMBER OF PRODUCTS CANNOT BE DETERMINED AS A PATIENT CAN EXPERIENCE MORE THAN ONE ADVERSE EVENT. THE FOLLOWING ACCOUNTS FOR ANY NEW ADVERSE EVENTS THAT WERE NOT PREVIOUSLY REPORTED AT 7 AND 30 DAYS OF THE INDEX ABLATION: ADVERSE EVENT(S) REPORTED FOR THERMOCOOL SMARTTOUCH CATHETER FOR CARDIAC ABLATION PROCEDURE FOR 90 DAYS OF INDEX PROCEDURE NOT PREVIOUSLY CAPTURED: QTY 1 TRANSIENT ISCHEMIC ATTACK WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 2 PERICARDITIS WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 1 DIAPHRAGMATIC PARALYSIS WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 17 PULMONARY EDEMA WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 1 MAJOR VASCULAR ACCESS COMPLICATION OR BLEEDING REQUIRING TRANSFUSION WITHIN 90 DAYS OF THE INDEX ABLATION. ADVERSE EVENT(S) REPORTED FOR THERMOCOOL SMARTTOUCH SF CATHETER FOR CARDIAC ABLATION PROCEDURE FOR 90 DAYS OF INDEX PROCEDURE NOT PREVIOUSLY CAPTURED: QTY 1 DEATH WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 1 ACUTE MYOCARDIAL INFARCTION WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 3 ACUTE STROKE/CEREBROVASCULAR ACCIDENT WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 1 TRANSIENT ISCHEMIC ATTACK WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 1 THROMBOEMBOLISM WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 2 PERICARDITIS WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 1 DIAPHRAGMATIC PARALYSIS WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 22 PULMONARY EDEMA WITHIN 90 DAYS OF THE INDEX ABLATION, QTY 2 CARDIAC TAMPONADE/PERFORATION 90 DAYS OF THE INDEX ABLATION, QTY 1 ATRIOESOPHAGEAL FISTULA WITHIN 90 DAYS OF THE INDEX ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902426 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| D