BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 19629966 · Received June 27, 2024

    Report

    Report Number
    2029046-2024-02132
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    April 2, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: SIMPSON J, AL-SADAWI M, DESHMUKH A, LIANG JJ, LATCHAMSETTY R, CRAWFORD T, JONGNARANGSIN K, ORAL H, BOGUN F, GHANNAM M. CATHETER ABLATION OF PARAHISIAN PREMATURE VENTRICULAR COMPLEXES IN PATIENTS WITH AND WITHOUT CARDIAC SCAR. HEART RHYTHM. 2024 APR 2:S1547-5271(24)02308-7. DOI: 10.1016/J.HRTHM.2024.03.1813. EPUB AHEAD OF PRINT. PMID: 38574787. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND ABLATION OF PREMATURE VENTRICULAR COMPLEXES (PVCS) ORIGINATING FROM THE PARAHISIAN AREA IS CHALLENGING. LATE GADOLINIUM-ENHANCED CARDIAC MAGNETIC RESONANCE (LGE-CMR) SCAR MAY INFLUENCE PROCEDURAL OUTCOMES; THE IMPACT OF CARDIAC SCAR ON PARAHISIAN PVCS HAS NOT BEEN DESCRIBED. OBJECTIVE THE OBJECTIVE OF THIS STUDY WAS TO EXAMINE THE INCIDENCE AND SIGNIFICANCE OF LGE-CMR SCARRING IN PATIENTS UNDERGOING ABLATION FOR PARAHISIAN PVCS. METHODS CONSECUTIVE PATIENTS WHO UNDERWENT PREPROCEDURE LGE-CMR IMAGING AND ABLATION OF PARAHISIAN PVCS WERE INCLUDED. ACUTE AND LONG-TERM OUTCOMES WERE EXAMINED. RESULTS FORTY-EIGHT PATIENTS WERE INCLUDED (MALE, N 5 37; AGE, 66 6 10 YEARS; EJECTION FRACTION, 50% 6 12%; PREPROCEDURE PVC BURDEN, 21% 6 12%). INTRAMURAL LGE-CMR SCAR WAS PRESENT IN 33 OF 48 (69%) PATIENTS. CRYOABLATION WAS USED IN 9 PATIENTS; ABLATION IN MULTIPLE CHAMBERS WAS REQUIRED IN 28 (58%) PATIENTS. THE PVC SITE OF ORIGIN (SOO) WAS INTRAMURAL (N 5 25 PATIENTS), LEFT VENTRICULAR (N 5 5), AND RIGHT VENTRICULAR (N 5 18). PATIENTS WITH LGE-CMR SCAR WERE MORE LIKELY TO HAVE INTRAMURAL PVCS (64% VS 27%; P < .04) AND TO REQUIRE ABLATION IN MULTIPLE CARDIAC CHAMBERS (58% VS 13%; P < .02). PATIENTS WITH INTRAMURAL SCAR REQUIRED LONGER DURATION OF ABLATION DELIVERY (31 6 20 MINUTES VS 17 6 8 MINUTES; P < .02). ACUTE PROCEDURAL SUCCESS WAS 69%; PVC BURDEN ON FOLLOW-UP WAS 6% 6 9% AND SIMILAR FOR THOSE WITH AND WITHOUT SCAR. CONCLUSION ABLATION OF PARAHISIAN PVCS OFTEN REQUIRES MAPPING AND ABLATION OF MULTIPLE CARDIAC CHAMBERS, WITH AN INTRAMURAL SOO IDENTIFIED IN MOST PATIENTS. AN INTRAMURAL SCAR WAS ASSOCIATED WITH AN INTRAMURAL SOO OF THE PVCS REQUIRING MORE EXTENSIVE ABLATION PROCEDURES, WITH SIMILAR LONG-TERM OUTCOMES COMPARED WITH THOSE WITHOUT SCAR. THE COMPLICATION OF VASCULAR ACCESS SITE HEMATOMA IS ASSOCIATED WITH USE OF A SHEATH. A STEPWISE APPROACH WAS USED BEGINNING WITH RADIOFREQUENCY ENERGY WITH MONITORING FOR JUNCTIONAL RHYTHM AND DISCONTINUING ENERGY IN THE PRESENCE OF PR PROLONGATION OR ATRIOVENTRICULAR (AV) BLOCK. IN THESE CASES, FOCAL CRYOABLATION WAS PERFORMED AT THE DISCRETION OF THE OPERATING PHYSICIAN WITH A 6-MM-TIP CATHETER (FREEZOR XTRA; MEDTRONIC, MINNEAPOLIS, MN). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE WEBSTER DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH SURROUND FLOW. CONCOMITANT OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: CARTO MAPPING SYSTEM, FREEZOR XTRA CRYOABLATION CATHETER (MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH SMARTTOUCH SURROUND FLOW. QTY 5 NEW BUNDLE BRANCH BLOCK (HEART BLOCK) THAT DID NOT REQUIRE ADDITIONAL MANAGEMENT (RECOGNIZED PROCEDURAL COMPLICATION). QTY 1 COMPLETE AV BLOCK (HEART BLOCK AV) OCCURRED IN 1 PATIENT WITH A PREEXISTING BIVENTRICULAR CIED DURING EXTENSIVE ABLATION FOR AN INDUCED VT THAT WAS BASAL-SEPTAL IN ORIGIN (RECOGNIZED PROCEDURAL COMPLICATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2183970 SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other