BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 19629100 · Received June 27, 2024

    Report

    Report Number
    2029046-2024-02130
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    April 3, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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. MANUFACTURER'S REF. NO: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: NAKASONE K, MORI S, IZAWA Y, IMAMURA K, TAKAMI M, HIRATA KI, FUKUZAWA K. LEFT HEMOTHORAX DURING PULMONARY VEIN ISOLATION. JACC CLIN ELECTROPHYSIOL. 2024 JUN;10(6):1223-1231. DOI: 10.1016/J.JACEP.2024.02.018. EPUB 2024 APR 3. PMID: 38573290. OBJECTIVE/METHODS/STUDY DATA: A CASE OF PERSISTENT ATRIAL FIBRILLATION COMPLICATED BY LEFT HEMOTHORAX DURING CATHETER ABLATION. THE PATIENT REMAINED ASYMPTOMATIC WITH STABLE VITAL SIGNS IN THE WARD. HOWEVER, COMPARING PREPROCEDURAL AND POSTPROCEDURAL CHEST RADIOGRAPHS REVEALED SUBSTANTIAL LEFT LUNG HYPOLUCENCY AND POSITIVE SILHOUETTE SIGNS IN THE HEART, DESCENDING AORTA, AND DIAPHRAGM. THIS PROMPTED PLAIN CHEST COMPUTED TOMOGRAPHY. COMPARED WITH THE AXIAL IMAGE BEFORE THE PROCEDURE, THE POSTPROCEDURAL AXIAL IMAGE REVEALED LEFT PLEURAL EFFUSION (YELLOW ASTERISKS) WITH A HIGHER ATTENUATION VALUE (50 HOUNSFIELD UNITS), INDICATING LEFT HEMOTHORAX. THE LEFT INFERIOR PULMONARY VEIN SHOWED CONTINUITY WITH THE HEMOTHORAX. A TOTAL OF 1,500 ML OF BLOODY PLEURAL EFFUSION WAS DRAINED. POSTPROCEDURAL HEMOGLOBIN DROPPED FROM 14.7 TO 11.7 G/DL, YET NO BLOOD TRANSFUSION WAS REQUIRED. ORAL ANTICOAGULATION (APIXABAN 5 MG, TWICE DAILY) WAS RESUMED ON POSTPROCEDURAL DAY 5 BECAUSE NO FURTHER FLUID ACCUMULATION OR HEMOGLOBIN DECREASE WAS OBSERVED. THE DRAINAGE TUBE WAS REMOVED ON DAY 9, AND THE PATIENT WAS DISCHARGED ON DAY 15. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE WEBSTER DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL STSF CATHETER ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH THERMOCOOL STSF CATHETER: QTY 1 HEMOTHORAX (PLEURAL EFFUSION) TREATED BY DRAINAGE TUBE (SURGICAL INTERVENTION)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828771 SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention