BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER.

    MDR report key: 16001852 · Received December 18, 2022

    Report

    Report Number
    2029046-2022-03166
    Event Type
    Injury
    Date Received
    December 18, 2022
    Date of Event
    August 16, 2022
    Report Date
    December 18, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 803. 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 DURING A BWI CLINICAL STUDY AN UNKNOWN 71-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2021 WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED DYSPNEA D'EFFORT. PER THE STUDY INVESTIGATOR THE SEVERITY WAS SEVERE, THE ADVERSE EVENT IS SERIOUS, AND THE PATIENT DID NOT DIE. THERE WAS A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT, AS DEFINED AS CONSIDERED A LIFE-THREATENING ILLNESS OR INJURY AND/OR A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION INCLUDING CHRONIC DISEASES. IN-PATIENT OR PROLONGATION HOSPITALIZATION WAS REQUIRED FROM (B)(6) 2022. NO MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION WAS REQUIRED. RELATIONSHIP TO STUDY PROCEDURE IS CAUSAL. IT IS RELATED TO THE INDEX PROCEDURE. THE PATIENT OUTCOME IS RECOVERED/RESOLVED. THERE WAS INTERVENTION/ TREATMENT, MEDICATION WAS GIVEN, NO CARDIOVERSION OR SURGERY WAS PERFORMED. IT WAS NOT A RE-ABLATION PROCEDURE. NO OTHER INTERVENTION WAS PROVIDED. THE EVENT IS EXPECTED/ANTICIPATED. PER THE STUDY INVESTIGATOR STATED THE RELATIONSHIP TO THE STUDY DEVICES SHEATH, THERMOCOOL, DIAGNOSTIC CATHETER, NGEN, AND CARTO IS NOT RELATED. THIS COMPLAINT WILL BE CONSERVATIVELY REPORTED AS PER STUDY INVESTIGATOR THERE WAS A CAUSAL RELATIONSHIP WITH THE PROCEDURE AND IT WAS REPORTED THAT THERE WAS A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126231 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D132705 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R| L CARTO 3 SYSTEM| PENTARAY CATHETER