BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 19625623 · Received June 27, 2024

    Report

    Report Number
    2029046-2024-02120
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    January 12, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: ZHAO Y, YUAN X, XIE Y, YIN X, LIU Y, SUN Y, GONG Y, LIU J, CHEN F. ASSOCIATION OF PREABLATION PLASMA CORIN LEVELS WITH ATRIAL FIBRILLATION RECURRENCE AFTER CATHETER ABLATION: A PROSPECTIVE OBSERVATIONAL STUDY. J AM HEART ASSOC. 2024 JAN 16;13(2):E031928. DOI: 10.1161/JAHA.123.031928. EPUB 2024 JAN 12. PMID: (B)(6); PMCID: (B)(6). OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: WE ASSESSED THE IMPACT OF PRE- AND POSTPROCEDURAL PLASMA CORIN LEVELS ON THE RECURRENCE OF ATRIAL FIBRILLATION (AF) AFTER CATHETER ABLATION (CA). METHODS AND RESULTS: THIS PROSPECTIVE, SINGLE-CENTER, OBSERVATIONAL STUDY INCLUDED PATIENTS UNDERGOING THEIR FIRST CA OF AF. CORIN WAS MEASURED BEFORE AND 1 DAY AFTER CA. THE PRIMARY END POINT WAS RECURRENT AF BETWEEN 3 AND 12 MONTHS AFTER ABLATION. FROM APRIL 2019 THROUGH MAY 2021, WE ANALYZED 616 PATIENTS WITH AF (59.09% MEN) WITH A MEAN AGE OF 62.86±9.42 YEARS. OVERALL, 153 PATIENTS (24.84%) EXPERIENCED RECURRENT AF. IN THE RECURRENCE GROUP, THE PRE- AND POSTPROCEDURE CORIN CONCENTRATIONS WERE 539.14 (329.24-702.08) AND 607.37 (364.50-753.80) PG/ML, RESPECTIVELY, WHICH WERE SIGNIFICANTLY HIGHER THAN THE NONRECURRENCE GROUP'S RESPECTIVE CONCENTRATIONS OF 369.05 (186.36-489.28) AND 489.12 (315.66-629.05) PG/ML (BOTH P<0.0001). A MULTIVARIATE COX REGRESSION ANALYSIS WITH CONFOUNDERS FOUND THAT ELEVATED PREABLATION CORIN LEVELS WERE SIGNIFICANTLY ASSOCIATED WITH AN INCREASED RISK OF AF RECURRENCE AFTER CA. RECEIVER OPERATING CHARACTERISTIC CURVE ANALYSIS IDENTIFIED THAT A PREABLATION CORIN THRESHOLD OF >494.85 PG/ML PREDICTED AF RECURRENCE AT 1 YEAR. AN INCREASE OF 1 SD IN CORIN CONCENTRATIONS BEFORE CA (264.94 PG/ML) INCREASED THE RISK OF RECURRENT AF BY 54.3% AFTER ADJUSTING FOR CONFOUNDING VARIABLES (HAZARD RATIO, 1.465 [95% CI, 1.282-1.655]; P<0.0001). CONCLUSIONS: PLASMA CORIN LEVELS AT BASELINE IS A VALUABLE PREDICTOR OF AF RECURRENCE AFTER CA, INDEPENDENT OF ESTABLISHED CONVENTIONAL RISK FACTORS. RISK STRATIFICATION BEFORE ABLATION FOR AF MAY BE USEFUL IN SELECTING TREATMENT REGIMENS FOR PATIENTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: PENTARAY, CARTO 3 SYSTEM. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: 8.5-F LONG SHEATHS (SL1, ST. JUDE MEDICAL). GROIN SITE COMPLICATION WAS REPORTED, BUT A NON-BWI SHEATH WAS USED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF: QTY 1: ONE PATIENT HAD (CARDIAC PERFORATION) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT). QTY 1: ONE PATIENT HAD HEMORRHAGIC STROKE (CEREBROVASCULAR ACCIDENT) (RECOGNIZED PROCEDURAL COMPLICATION) (ADVERSE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481735 SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening