BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL

    MDR report key: 15272823 · Received August 23, 2022

    Report

    Report Number
    2029046-2022-01952
    Event Type
    Injury
    Date Received
    August 23, 2022
    Date of Event
    June 23, 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
    GM
    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:STEINFURT J, DALL'AGLIO PB, HUGENSCHMIDT J, STUPLICH J, JÄCKEL M, JORDAN E, LEHRMANN H, FABER TS, GRESSLER A, JADIDI AS, WESTERMANN D, ARENTZ T, TROLESE L. INITIAL CLINICAL EXPERIENCE WITH A NOVEL 8-SPLINE HIGH-RESOLUTION MAPPING CATHETER. JACC CLIN ELECTROPHYSIOL. 2022 JUN 23:S2405-500X(22)00467-4. DOI: 10.1016/J.JACEP.2022.05.010. EPUB AHEAD OF PRINT. PMID: 35780035. 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:STEINFURT J, DALL'AGLIO PB, HUGENSCHMIDT J, STUPLICH J, JÄCKEL M, JORDAN E, LEHRMANN H, FABER TS, GRESSLER A, JADIDI AS, WESTERMANN D, ARENTZ T, TROLESE L. INITIAL CLINICAL EXPERIENCE WITH A NOVEL 8-SPLINE HIGH-RESOLUTION MAPPING CATHETER. JACC CLIN ELECTROPHYSIOL. 2022 JUN 23:S2405-500X(22)00467-4. DOI: 10.1016/J.JACEP.2022.05.010. EPUB AHEAD OF PRINT. PMID: 35780035. OBJECTIVE/METHODS/STUDY DATA: : THIS STUDY SOUGHT TO REPORT THE INITIAL CLINICAL MAPPING EXPERIENCE WITH THE NOVEL 8-SPLINE OCTARAY MAPPING CATHETER IN A VARIETY OF CARDIAC ARRHYTHMIAS AND TO COMPARE THE MAPPING PERFORMANCE WITH THE 5-SPLINE PENTARAY. S FIFTY CONSECUTIVE PROCEDURES AMONG 46 PATIENTS WERE RETROSPECTIVELY ANALYZED REGARDING SAFETY, EFFICACY, AND ACUTE PROCEDURAL SUCCESS DEFINED AS TERMINATION OR NONINDUCIBILITY OF CLINICAL TACHYCARDIA, CONDUCTION BLOCK ACROSS AN ABLATION LINE, OR PULMONARY VEIN ISOLATION. IN ADDITION, ANOTHER 10 PATIENTS WITH SUSTAINED ATRIAL TACHYCARDIA MAPPED WITH THE 5-SPLINE CATHETER (2-5-2 SPACING) OR THE NOVEL 8-SPLINE CATHETER (2-2-2-2-2 SPACING) WERE ANALYZED. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH OR SMARTTOUCH SF. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: STEERABLE SHEATH 8.5F VIZIGO, 5-SPLINE PENTARAY MAPPING CATHETER, NOVEL 8-SPLINE OCTARAY MAPPING CATHETER NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: STEERABLE SHEATH 8.5F AGILIS NXT (ABBOTT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (ASSOCIATED WITH ABLATION CATHETER): QTY 1 PERICARDIAL EFFUSION (NOT RELATED TO MAPPING) - NO FURTHER INFORMATION PROVIDED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (INSUFFICIENT INFORMATION TO ASSOCIATE WITH SPECIFIC MANUFACTURER'S DEVICE): QTY 2 ARTERIOVENOUS FISTULAS/HEMATOMAS - NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388620 UNK_SMART TOUCH UNIDIRECTIONAL CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening