BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 18924069 · Received March 18, 2024

    Report

    Report Number
    2029046-2024-00881
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    September 13, 2023
    Report Date
    March 18, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DHAKAL BP, PATEL NA, GARG L, FRANKEL DS, HYMAN MC, GUANDALINI GS, SUPPLE GE, NAZARIAN S, KUMARESWARAN R, RILEY MP, SANTANGELI P, LIN D, CALLANS DJ, ARKLES J, SCHALLER RD, TSCHABRUNN CM, ZADO ES, MARCHLINSKI FE, DIXIT S. UTILITY OF VERY HIGH-OUTPUT PACING TO IDENTIFY VT CIRCUITS IN PATIENTS MANIFESTING TRADITIONALLY INEXCITABLE SCAR. JACC CLIN ELECTROPHYSIOL. 2023 DEC;9(12):2523-2533. DOI: 10.1016/J.JACEP.2023.08.015. EPUB 2023 SEP 13. PMID: 37715743. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DHAKAL BP, PATEL NA, GARG L, FRANKEL DS, HYMAN MC, GUANDALINI GS, SUPPLE GE, NAZARIAN S, KUMARESWARAN R, RILEY MP, SANTANGELI P, LIN D, CALLANS DJ, ARKLES J, SCHALLER RD, TSCHABRUNN CM, ZADO ES, MARCHLINSKI FE, DIXIT S. UTILITY OF VERY HIGH-OUTPUT PACING TO IDENTIFY VT CIRCUITS IN PATIENTS MANIFESTING TRADITIONALLY INEXCITABLE SCAR. JACC CLIN ELECTROPHYSIOL. 2023 DEC;9(12):2523-2533. DOI: 10.1016/J.JACEP.2023.08.015. EPUB 2023 SEP 13. PMID: 37715743. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: ENTRAINMENT AND PACE MAPPING ARE USED TO IDENTIFY CRITICAL COMPONENTS (CCS) OF VENTRICULAR TACHYCARDIA (VT) CIRCUITS. IN PATIENTS WITH DENSE MYOCARDIAL SCARRING, VT CIRCUITS MAY ELUDE CAPTURE AT STANDARD HIGH PACING OUTPUTS (UP TO 10 MA AT A 2-MILLISECOND PULSE WIDTH). OBJECTIVES: THE PURPOSE OF THIS STUDY WAS TO ASSESS THE UTILITY OF VERY HIGH-OUTPUT PACING (V-HOP, 50 MA AT 2 MILLISECONDS) FOR IDENTIFYING CCS OF VT CIRCUITS AFTER STANDARD HIGH PACING OUTPUT FAILED TO ELICIT CAPTURE IN DENSELY SCARRED MYOCARDIAL TISSUE. METHODS: OUR STANDARD VT ABLATION APPROACH INCLUDED ELECTROANATOMIC MAPPING FOR SUBSTRATE CHARACTERIZATION AND ENTRAINMENT AND/OR PACE MAPPING TO IDENTIFY CCS OF VT CIRCUITS. PATIENTS THAT REQUIRED V-HOP TO CAPTURE SITES OF INTEREST COMPRISED THE STUDY COHORT. ABLATION ENDPOINTS WERE VT TERMINATION AND NONINDUCIBILITY. RESULTS: TWENTY-FIVE PATIENTS (71 ± 10 YEARS OF AGE, ALL MALES) UNDERGOING 26 VT ABLATIONS MET THE INCLUSION CRITERIA. THE MEAN LEFT VENTRICULAR EJECTION FRACTION WAS 30% ± 14%, AND 85% HAD ISCHEMIC CARDIOMYOPATHY. V-HOP WAS USED TO SUCCESSFULLY ENTRAIN VT IN 17 PATIENTS, YIELDING CENTRAL ISTHMUS SITES IN 10 AND ENTRANCE/EXIT SITES IN 4. VT TERMINATED WITH RADIOFREQUENCY ABLATION AT THESE SITES IN 15 PATIENTS. IN 9 PATIENTS, V-HOP IDENTIFIED SCAR LOCATIONS WITH A DELAYED EXIT. ACUTE PROCEDURAL SUCCESS WAS ACHIEVED IN 24 PATIENTS WITHOUT ANY ADVERSE EVENTS. OVER A FOLLOW-UP PERIOD OF 16 ± 21 MONTHS, 2 PATIENTS EXPERIENCED VT RECURRENCE REQUIRING REPEAT ABLATION DURING WHICH THE SAME LOCATION WAS TARGETED SUCCESSFULLY IN 1 PATIENT. CONCLUSIONS: IN VT PATIENTS WITH A DENSE SCAR THAT IS TRADITIONALLY INEXCITABLE, V-HOP CAN IDENTIFY CCS OF THE RE-ENTRANT CIRCUIT AND GUIDE SUCCESSFUL ABLATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SF ABLATION CATHETER. CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO MAPPING SYSTEM, PENTARAY MAPPING CATHETER. CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: BLOOM STIMULATOR (FISCHER MEDICAL). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNIDENTIFIED THERMOCOOL SMARTTOUCH SF ABLATION CATHETER: QTY PROGRAMMED STIMULATION WAS NOT PERFORMED AT THE END OF THE PROCEDURE BECAUSE OF HEMODYNAMIC INSTABILITY DUE TO PERSISTENT (HYPOTENSION) AND NO INFORMATION PROVIDED REGARDING INTERVENTIONS (INSUFFICIENT INFORMATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179066 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other BLOOM STIMULATOR (FISCHER MEDICAL).| CARTO MAPPING SYSTEM.| PENTARAY MAPPING CATHETER.