BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THMCL SMTCH SF BID, TC, F-J

    MDR report key: 9160087 · Received October 5, 2019

    Report

    Report Number
    2029046-2019-03729
    Event Type
    Injury
    Date Received
    October 5, 2019
    Date of Event
    September 7, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW ON (B)(6)2019 , THIS EVENT UNDER THIS PRODUCT ¿THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER¿ WAS REASSESSED FROM A ¿SERIOUS INJURY¿ TO CONCOMITANT PRODUCT WHICH IS ¿NOT REPORTABLE¿. HOWEVER, SINCE IT HAS ALREADY BEEN REPORTED TO THE FDA, ANY ADDITIONAL UPDATES RECEIVED WILL CONTINUE TO BE REPORTED. THEREFORE, THIS PRODUCT WAS ADDED TO THE D11. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES SECTION. ON (B)(6)2019 , IT WAS NOTICED THAT THE CONCOMITANT PRODUCT WAS INADVERTENTLY OMITTED FROM THE 3500A INITIAL MDR SUBMITTED TO FDA ON 10/5/2019. THE PRODUCT HAS NOW BEEN ADDED TO SECTION D11. CONCOMITANT MED PRODUCTS. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 30240592M 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

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT CARDIAC ABLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. ON (B)(6) 2019, POST-PROCEDURE DAY 1, THE PATIENT SUFFERED BLEEDING FROM THE LEFT ACCESS SITE IN THE GROIN, REQUIRING SURGICAL INTERVENTION. NO EXTENDED HOSPITALIZATION WAS REQUIRED. AN UNSPECIFIED MEDICATION WAS ADMINISTERED, AND THE ISSUE RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, NOT RELATED TO THE STUDY DEVICE (VISITAG SURPOINT EPU), NOT RELATED TO THE STUDY CATHETERS, NOT RELATED TO BIOSENSE WEBSTER, INC. NON-INVESTIGATIONAL DEVICE AND CAUSALLY RELATED TO THE STUDY PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, THIS EVENT WAS EXPECTED. NO BIOSENSE WEBSTER, INC. PRODUCT DEFICIENCIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954191 THMCL SMTCH SF BID, TC, F-J CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 30240592M 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention CARTO 3 SYSTEM| CARTO3 EXTERNAL REFPATCH 6PACK| CBL, 34 HYP/34 LEMO, 10'| SMARTABLATE GENERATOR KIT-US| SMARTABLATE PUMP KIT-US| THMCL SMTCH SF BID, TC, F-J