BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 11646122 · Received April 9, 2021

    Report

    Report Number
    2029046-2021-00561
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    July 30, 2018
    Report Date
    March 25, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2021-00562 AND 2029046-2021-00563 ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 1 PATIENTS UNDERWENT PV ISOLATION AND SUFFERED TRANSIENT PHRENIC NERVE PALSY. INTERVENTION WAS NOT REPORTED. (THERMOCOOL SMARTTOUCH (ST)). MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS THERMOCOOL SMARTTOUCH (ST) . OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE. PUBLICATION DETAILS: TITLE: IMPACT OF ABLATION INDEX SETTINGS ON PULMONARY VEIN RECONNECTION. OBJECTIVE: ABLATION INDEX (AI) IS A RADIOFREQUENCY LESION QUALITY MARKER. THE AI VALUE THAT ALLOWS EFFECTIVE AND SAFE PULMONARY VEIN ISOLATION (PVI) IS STILL DEBATED. WE EVALUATED THE INCIDENCE OF ACUTE AND LATE PV RECONNECTION (PVR) WITH DIFFERENT AI SETTINGS AND ITS PREDICTORS. METHODS: S THE ABLATION INDEX REGISTRY IS A MULTICENTER STUDY THAT INCLUDED PATIENTS WITH PAROXYSMAL/PERSISTENT ATRIAL FIBRILLATION (AF) WHO UNDERWENT FIRST-TIME ABLATION. EACH OPERATOR PERFORMED THE ABLATION USING HIS PREFERRED ABLATION CATHETER (THERMOCOOL® SMARTTOUCH OR SURROUND FLOW) AND AI SETTING (380 POSTERIOR-500 ANTERIOR AND 330 POSTERIOR-450 ANTERIOR). WE DIVIDED THE STUDY POPULATION INTO TWO GROUPS ACCORDING TO THE AI SETTING USED: GROUP 1 (330¿450) AND GROUP 2 (380¿500). INCIDENCE OF ACUTE PVR WAS VALIDATED WITHIN 30 MIN AFTER PVI, WHEREAS THE INCIDENCE OF LATE PVR WAS EVALUATED AT REPEAT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536825 UNK_SMART TOUCH BIDIRECTIONAL SIMILAR DEVICE D132701, PMA # P030031/S053 OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other