BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9189420 · Received October 15, 2019

    Report

    Report Number
    2029046-2019-03760
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    May 31, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 6/5/2020, A CORRECTION WAS IDENTIFIED THAT THE CONCOMITANT PRODUCTS WERE NOT INCLUDED IN THE 3500A INITIAL REPORT. THEREFORE, PROCESSED THE "D11. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES" SECTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW ON (B)(6)2019 , IT WAS NOTED THAT A CORRECTION TO THE EVENT DESCRIPTION WAS NEEDED FOR THE PATIENT CONSEQUENCE AND INTERVENTION THAT WAS INITIALLY REPORTED ON THE INITIAL 3500 A REPORT SUBMITTED ON (B)(6)2019 . IN THE INITIAL 3500A REPORT (MWR-23092019-0000537867) SUBMITTED ON (B)(6)2019 , THE FOLLOWING WAS REPORTED: ¿A 23-YEAR-OLD MALE PATIENT (99.7KG, 203.2CM) UNDERWENT A CARDIAC ABLATION PROCEDURE ON (B)(6)2019 WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED MIGRAINE AND NUMBNESS TO UPPER AND LOW EXTREMITIES.¿ THE CORRECTION IS AS FOLLOWS: ¿A 23-YEAR-OLD MALE PATIENT (99.7KG, 203.2CM) UNDERWENT A CARDIAC ABLATION PROCEDURE ON MAY 29, 2019 WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED ATRIAL FIBRILLATION REQUIRING CARDIOVERSION.¿ MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED.  A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30097130M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    THIS EVENT IS ASSOCIATED WITH A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER, INC. IT WAS REPORTED THAT A (B)(6) MALE PATIENT ((B)(6)) UNDERWENT A CARDIAC ABLATION PROCEDURE ON (B)(6) 2019 WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED MIGRAINE AND NUMBNESS TO UPPER AND LOW EXTREMITIES. ON (B)(6) 2019, TWO MONTHS POST-PROCEDURE, THE PATIENT SUFFERED ATRIAL FIBRILLATION. INTERVENTION INCLUDED ELECTROCARDIOVERSION AND PHARMACOLOGICAL CARDIOVERSION. ADDITIONAL HOSPITALIZATION WAS NOT REQUIRED. THE PATIENT'S CONDITIONS RESOLVED AND RECOVERED. NO BIOSENSE WEBSTER, INC. PRODUCT DEFICIENCIES WERE REPORTED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, NOT SERIOUS, NOT RELATED TO STUDY DEVICE, NOT RELATED TO BIOSENSE WEBSTER, INC. NON-INVESTIGATIONAL, POSSIBLY RELATED TO THE STUDY PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, THIS EVENT WAS NOT EXPECTED. DURING THE PROCEDURE, 69 RADIO FREQUENCY APPLICATIONS WERE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985505 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132705 30097130M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention CARTO3 EXTERNAL REFPATCH 6PACK| CBL, 34 HYP/34 LEMO, 10'| SMARTABLATE GENERATOR KIT-US