BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER A

    MDR report key: 19523385 · Received June 12, 2024

    Report

    Report Number
    2029046-2024-01920
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    May 16, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31265462L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. E1. INITIAL REPORTER PHONE: (B)(6). MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND DURING THE ABLATION PHASE, THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED, PATIENT'S VITAL SIGNS AND BLOOD PRESSURE DROPPED, CARDIAC TAMPONADE WAS SUSPECTED, AND THEN PERICARDIAL EFFUSION WAS CONFIRMED. DRAINAGE WAS PERFORMED AND THE PATIENT'S CONDITION WAS STABILIZED. ATRIAL SEPTAL PUNCTURE WAS PERFORMED WITH AND RF NEEDLE. THE PHYSICIAN COMMENTED THAT THE NEWER PHYSICIAN MIGHT HAVE ACCIDENTALLY APPLIED TOO MUCH CONTACT FORCE, BUT THE EXACT CAUSAL RELATIONSHIP HAS NOT BEEN IDENTIFIED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF STEAM POP. THE PATIENT FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390754 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER A CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31265462L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Life Threatening| R OCTA,STD,48P,2-2-2-2-2,D-CURVE| SMARTABLATE GEN. KIT (JAPAN)| SOUNDSTAR ECO SMS 8F CATHETER| UNK RF NEEDLE| UNK_CARTO 3