BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 17967577 · Received October 19, 2023

    Report

    Report Number
    2029046-2023-02380
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    September 25, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE 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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED BY THE CALLER, A BWI REPRESENTATIVE, THAT SOMETIME AFTER THE CASE WAS COMPLETED AND THE PATIENT HAD BEEN MOVED TO THE RECOVERY ROOM, A DROP IN BLOOD PRESSURE WAS OBSERVED AND THE CALLER STATED THAT THE PATIENT WAS MOVED BACK TO THE ELECTROPHYSIOLOGY (EP) LAB. A TRANSTHORACIC ECHO CONFIRMED A PERICARDIAL EFFUSION. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS 900ML OF FLUID WAS REMOVED AND A DRAIN WAS ALSO ADDED. THE PHYSICIAN IS UNAWARE OF WHEN THIS COULD HAVE HAPPENED. EVERYTHING DURING THE CASE WAS COMPLETED WITH NO OTHER ISSUES. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN IS UNSURE WHAT CAUSED THE EVENT. THE PATIENT HAD A PERSISTENT LEFT SUPERIOR VENA CAVA, WHICH MADE TRANSSEPTAL MORE DIFFICULT THAN USUAL AND MAY HAVE CONTRIBUTED. THE PATIENT¿S OUTCOME WAS REPORTED AS ¿FULLY RECOVERED¿. PATIENT REQUIRED EXTENDED HOSPITALIZATION FOR MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96194 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| L| R BAYLIS MEDICAL VERSACROSS NEEDLE.| CARTO 3 SYSTEM.| SMARTABLATE GENERATOR KIT-US.| UNKNOWN PUMP.