BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 10304063 · Received July 21, 2020

    Report

    Report Number
    2029046-2020-00905
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    March 29, 2020
    Report Date
    June 22, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/31/2020, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE PATIENT AND EVENT. IT WAS REPORTED THE PATIENT IN THIS PROCEDURE WAS A 54 YEAR OLD MALE AND THE PATIENTS CONDITION IMPROVED. IT WAS ALSO REAFFIRMED THAT THE ADVERSE EVENT WAS DISCOVERED POST USE. PATIENT¿S HEALTH HISTORY WAS REPORTED WITH HYPERURICEMIA, IRON DEFICIENCY ANEMIA AND HAS BEEN ADDED TO FIELD B6. ON 9/24/2020, THE NAME OF THE FACILITY IN WHICH THIS ADVERSE EVENT OCCURRED WAS REPORTED AS ¿(B)(6)¿. AS SUCH, THE APPROPRIATE FIELDS IN SECTION E1. INITIAL REPORTER HAVE BEEN POPULATED. E1. INITIAL REPORTER: (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: ON (B)(6) 2020 IT WAS NOTICED THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE 3500A SUPPLEMENTAL MDR #1: DEVICE INVESTIGATION DETAILS: SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4). ADDITIONAL CORRECTION: PLEASE NOTE, THIS PROCEDURE WAS NOT PART OF A BIOSENSE WEBSTER INC. (BWI) SPONSORED CLINICAL TRIAL AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE FACILITY, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. INITIAL REPORTER PHONE: (B)(6). A REQUEST HAS BEEN SENT TO CLARIFY THE FACILITY NAME AND ADDRESS. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL SPONSORED BY BIOSENSE WEBSTER INC. (BWI), IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2020 WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND DEVELOPED ACUTE PARALYTIC GASTRIC DILATION (NERVE INJURY) REQUIRING PROLONGED HOSPITALIZATION. DURING THE PROCEDURE, THE ABLATION WAS CONDUCTED WITH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT IMMEDIATE PATIENT CONSEQUENCE. ON POST-PROCEDURE DAY 3 (B)(6) 2020), THE PATIENT DEVELOPED ACUTE PARALYTIC GASTRIC DILATION (NERVE INJURY). THERE¿S NO INDICATION THAT ANY MEDICAL/SURGICAL INTERVENTION WAS PROVIDED. PROLONGED HOSPITALIZATION WAS REQUIRED. ISSUE WAS RESOLVED. THE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS SERIOUS, NOT RELATED TO THE DEVICE AND RELATED TO THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765729 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization