BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15308452 · Received August 29, 2022

    Report

    Report Number
    2029046-2022-02013
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    July 27, 2022
    Report Date
    September 29, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). 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 WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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).

    Additional Manufacturer Narrative · 0

    ON 15-SEP-2022, BWI RECEIVED ADDITIONAL INFORMATION WHICH CLARIFIED ¿THE TEMPORAL RELATIONSHIP TO THE EXAMINATION IS STRIKING". CLINICAL IN CHARGE STATED THAT THE NIGHT AFTER THE CARTO EXAMINATION, PATIENT WAS COMPLAINING ABOUT HEADACHE. AN MRI OF THE HEAD WAS CARRIED OUT DURING WHICH THE LESIONS WERE VISIBLE. IT WAS ALSO VISIBLE THAT THE LESIONS WERE "FRESH" (NEW). IN TERMS OF TIME-FRAME AND TYPE OF INTERVENTION IT IS LIKELY THAT THIS (I.E. THE INTERVENTION) COULD HAVE CAUSED THE ISSUE / EXPLAINS THE NOTICED EFFECT. CONSERVATIVELY THE SMART TOUCH AND OCTARAY WILL BE CONSIDERED REPORTABLE AS ABLATION WAS PERFORMED AND THE PHYSICIAN SUPPOSED THAT THE OCTARAY COULD BE THE CAUSE SO IT IS DIFFICULT TO DETERMINE WHICH DEVICE CONTRIBUTED TO THE EVENT. 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 AN UNKNOWN MALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE AND A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT EXPERIENCED DOUBLE IMAGES AND SUFFERED CEREBRAL ISCHEMIC LESIONS AFTER AND ABLATION PROCEDURE. THE PATIENT REPORTED HE SEES DOUBLE IMAGES AFTER PULMONARY VEIN ISOLATION (PVI) PROCEDURE WITH OCTARAY. PHYSICIAN PERFORMED A MRT AND CT. HE FOUND SUB-ACUTE CEREBRAL ISCHEMIC LESIONS. A SMARTTOUCH SF (DF D134805) ABLATION CATHETER WAS USED; BUT PHYSICIAN SUPPOSED THAT THE OCTARAY (D160901) CATHETER COULD BE THE CAUSE. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN HAS NO IDEA WHERE THE CAUSE CAME FROM. IT COULD BE THE CATHETER OR THE PATIENT'S HEALTH CONSTITUTION. HOWEVER, THE TEMPORAL RELATIONSHIP TO THE EXAMINATION IS STRIKING. INTERVENTION BEING PROVIDED WAS AFIB PVI. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT FOR OBSERVATION. A OSYPKA HAT 500® GENERATOR SYSTEM WAS USED. CONSERVATIVELY THE SMART TOUCH AND OCTARAY WILL BE CONSIDERED REPORTABLE AS ABLATION WAS PERFORMED AND THE PHYSICIAN SUPPOSED THAT THE OCTARAY COULD BE THE CAUSE SO IT IS DIFFICULT TO DETERMINE WHICH DEVICE CONTRIBUTED TO THE EVENT. THIS REPORT IS FOR THE SMART TOUCH. THE OCTARAY WAS REPORTED IN MANUFACTURER REPORT NUMBER 2029046-2022-02014. 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
    2374760 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| R OSYPKA HAT 500® GENERATOR.