BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 17163978 · Received June 20, 2023

    Report

    Report Number
    2029046-2023-01318
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    April 5, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: DI C, WANG Q, WU Y, LI L, LIN W. MONITORING SPIKE POTENTIAL AND ABRUPT IMPEDANCE RISE WITH CONCOMITANT TEMPERATURE/CONTACT FORCE CHANGE FOR TIMELY DETECTION OF THE OCCURRENCE OF "SILENT" OR "NONAUDIBLE" STEAM POP. J INTERV CARDIOL. 2023 APR 5;2023:8873404. DOI: 10.1155/2023/8873404. PMID: 37064642; PMCID: PMC10098411. 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: DI C, WANG Q, WU Y, LI L, LIN W. MONITORING SPIKE POTENTIAL AND ABRUPT IMPEDANCE RISE WITH CONCOMITANT TEMPERATURE/CONTACT FORCE CHANGE FOR TIMELY DETECTION OF THE OCCURRENCE OF "SILENT" OR "NONAUDIBLE" STEAM POP. J INTERV CARDIOL. 2023 APR 5;2023:8873404. DOI: 10.1155/2023/8873404. PMID: 37064642; PMCID: PMC10098411. OBJECTIVE/METHODS/STUDY DATA:TIS STUDY SOUGHT TO ASSESS THE FEASIBILITY OF MONITORING THE RECORDED SPIKE POTENTIAL AND ABRUPT RISE IN IMPEDANCE WITH CONCOMITANT TEMPERATURE AND/OR CF CHANGE AS AN INDICATOR FORTIMELY DETECTION OF THE OCCURRENCE OF ¿SILENT¿ OR ¿NONAUDIBLE¿ SP EVENTS, PARTICULARLY IN REGIONS WHERE THE RISK OF PERFORATION MAY BE OF CONCERN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 3.5 MM EXTERNALLY IRRIGATED-TIP ABLATION CATHETER (SMARTTOUCH, D CURVE OR F CURVE, BIOSENSE WEBSTER, DIAMOND BAR, CA, USA) OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: DECAPOLAR MAPPING CATHETER (LASSO, BIOSENSE WEBSTER, DIAMOND BAR, CA, USA), STEERABLE SHEATH (MOBICATH, BIOSENSE WEBSTER, DIAMOND BAR, CA, USA) WAS ADVANCED ALTERNATELY ONLY WHEN THE NONSTEERABLE SHEATH COULD NOT ADVANCE THE NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONSTEERABLE SHEATH (8.5 F SL1, ST. JUDE MEDICAL, ST. PAUL, MN, USA) COULD NOT ADVANCE THE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: 15 REPORTED STEAM POPS. 2 PATIENTS DEVELOPED PERICARDIAL TAMPONADE AND UNDERWENT DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013380 UNK_SMART TOUCH BIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening DECAPOLAR MAPPING CATHETER.| NONSTEERABLE SHEATH (8.5 F SL1, ST. JUDE MEDICAL.| STEERABLE SHEATH (MOBICATH).