BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 15272942 · Received August 23, 2022

    Report

    Report Number
    2029046-2022-01954
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 22, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: MAMCHUR S, CHICHKOVA T, KHOMENKO E, KOKOV A. PULMONARY VEINS MORPHOMETRIC CHARACTERISTICS AND SPATIAL ORIENTATION INFLUENCE ON ITS CRYOBALLOON ISOLATION RESULTS. DIAGNOSTICS (BASEL). 2022 MAY 26;12(6):1322. DOI: 10.3390/DIAGNOSTICS12061322. PMID: 35741132; PMCID: PMC9221566. 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 CITATION HAS BEEN REVIEWED: MAMCHUR S, CHICHKOVA T, KHOMENKO E, KOKOV A. PULMONARY VEINS MORPHOMETRIC CHARACTERISTICS AND SPATIAL ORIENTATION INFLUENCE ON ITS CRYOBALLOON ISOLATION RESULTS. DIAGNOSTICS (BASEL). 2022 MAY 26;12(6):1322. DOI: 10.3390/DIAGNOSTICS12061322. PMID: 35741132; PMCID: PMC9221566. OBJECTIVE/METHODS/STUDY DATA: AUTHORS COMPARED PROCEDURAL AND LONG-TERM OUTCOMES IN PATIENTS WHO UNDERWENT THEIR FIRST PROCEDURE OF PULMONARY VEIN ISOLATION (PVI) FOR AF WITH EITHER RADIOFREQUENCY ABLATION (RFA) (N = 108) OR CBA (N = 122; CRYOBALLOON ABLATION) AND ASSESSED THEIR INTERACTION WITH THE DIFFERENT PATTERN OF PV ANATOMY, MORPHOMETRIC CHARACTERISTICS, AND SPATIAL ORIENTATION. A RANDOMIZED, PROSPECTIVE, SINGLE-CENTER CONTROLLED STUDY WAS CONDUCTED, ENROLLING 230 PATIENTS WITH DRUG-REFRACTORY ATRIAL FIBRILLATION (AF). AUTHORS COMPARED PROCEDURAL AND LONG-TERM OUTCOMES OF PATIENTS WHO UNDERWENT THEIR FIRST PROCEDURE OF PULMONARY VEIN ISOLATION (PVI) FOR AF WITH EITHER RADIOFREQUENCY ABLATION (RFA) (N = 108) OR CBA (N = 122) AND ASSESSED THEIR INTERACTION WITH THE DIFFERENT PATTERN OF PV ANATOMY, MORPHOMETRIC CHARACTERISTICS, AND SPATIAL ORIENTATION. THE STUDY PERIOD WAS BETWEEN JANUARY 2018 AND MAY 2021. THIS COMPLAINT CAPTURES THE REPORTED ADVERSE EVENTS FOR THE RFA GROUP THAT UTILIZED BIOSENSE PRODUCTS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMARTTOUCH CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 CONCOMITANT NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A (THE CRYOBALLOON GROUP CONSISTED OF UNIDENTIFIED DEVICE MANUFACTURERS). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (RF GROUP THAT UTILIZED SMARTTOUCH CATHETER): QTY 2 TIAS - (NO FURTHER INFORMATION PROVIDED) INTERVENTIONS ARE NOT SPECIFIED; QTY 1 PERICARDITIS - INTERVENTIONS ARE NOT SPECIFIED; QTY 1 HEMOPERICARDIUM (ASSOCIATED WITH TRANSSEPTAL PUNCTURE - SHEATH AND PUNCTURE DEVICES ARE NOT IDENTIFIED) - TREATED WITH DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169524 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO 3