BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 18445849 · Received January 4, 2024

    Report

    Report Number
    2029046-2024-00053
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    December 8, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE 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 A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION / THROMBOSIS THAT REQUIRED PERICARDIOCENTESIS AND EVENTUALLY SURGICAL INTERVENTION. THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT. THE PHYSICIAN USED AN INTRACARDIAC ECHOCARGRAPHY (ICE) CATHETER AND NOTICED THE EFFUSION WHEN THE CASE WAS ALMOST DONE. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS USAGE OF A NEEDLE AND A SYRINGE TO EXTRACT BLOOD. THE PATIENT WAS TAPPED TWICE. THE FIRST TIME THE PATIENT WAS TAPPED IT LOOKED AS IF A CLOT HAD FORMED, SO THERE WAS NO BLEEDING IN THE PERICARDIUM. THE PATIENT WAS BROUGHT TO THE ICU WHERE THE "CLOT OR SOMETHING" HAD BECOME DISLODGED WHERE BLOOD STARTED TO COME OUT OF THE EFFUSION. THE PATIENT NEEDED TO BE TAPPED AGAIN. PATIENT HAS FULLY RECOVERED BUT REQUIRED EXTENDED HOSPITALIZATION FOR OBSERVATION. TRANSSEPTAL PUNCTURE WAS PERFORMED. NO EVIDENCE OF STEAM POP. NO CARDIAC SURGERY WAS REQUIRED. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PATIENT IS AWAITING A POTENTIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558961 UNK_SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L| H BAYLIS VERSACROSS RF WIRE VXSK0031| SMARTABLATE GENERATOR KIT-US| UNK_CARTO 3