BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 11615100 · Received April 5, 2021

    Report

    Report Number
    2029046-2021-00506
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    December 5, 2017
    Report Date
    March 16, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBERS: 2029046-2021-00505 AND 2029046-2021-00507 ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATION WAS REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 1 PATIENT UNDERWENT VENTRICULAR TACHYCARDIA (VT) ABLATION AND SUFFERED PULMONARY EDEMA. INTERVENTION WAS NOT REPORTED. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS SMART TOUCH CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: PENTARAY , CARTO, PENTARAY NAV. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: TACTICATH ABLATION CATHETER, ENSITE NAVX/VELOCITY/PRECISION (ABBOTT MEDICAL, : LIVEWIRE DUODECA (ABBOTT MEDICAL), ADVISOR¿ HD GRID MAPPING CATHETER (ABBOTT MEDICAL), LARGE CURVE AGILIS. PUBLICATION DETAILS: TITLE: IMPACT OF A HIGH-DENSITY GRID CATHETER ON LONG-TERM OUTCOMES FOR STRUCTURAL HEART DISEASE VENTRICULAR TACHYCARDIA ABLATION. OBJECTIVE: SUBSTRATE MAPPING HAS HIGHLIGHTED THE IMPORTANCE OF TARGETING DIASTOLIC CONDUCTION CHANNELS AND LATE POTENTIALS. DURING VENTRICULAR TACHYCARDIA (VT) ABLATION. STATE-OF-THE-ART MULTIPOLAR MAPPING CATHETERS HAVE ENHANCED MAPPING CAPABILITIES. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE WHETHER LONG-TERM OUTCOMES WERE IMPROVED WITH THE USE OF A HD GRID MAPPING. CATHETER COMBINING COMPLEMENTARY MAPPING STRATEGIES IN PATIENTS WITH STRUCTURAL HEART DISEASE VT. METHODS: CONSECUTIVE PATIENTS UNDERWENT VT ABLATION ASSIGNED TO EITHER HD GRID, PENTARAY, DUODECA, OR POINT-BY-POINT (PBYP). RF MAPPING CATHETERS. CLINICAL ENDPOINTS INCLUDED RECURRENT ANTI-TACHYCARDIA PACING (ATP), APPROPRIATE SHOCK, ASYMPTOMATIC NON-SUSTAINED VT, OR ALL-CAUSE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509745 UNK_SMART TOUCH BIDIRECTIONAL SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other ADVISOR¿ HD GRID MAPPING CATHETER (ABBOTT MEDICAL)| CARTO| ENSITE NAVX (ABBOTT)| LARGE CURVE AGILIS| LIVEWIRE DUODECA (ABBOTT MEDICAL)| PRECISION (ABBOTT)| TACTICATH ABLATION CATHETER| UNK_PENTARAY| UNK_PENTARAY NAV| VELOCITY (ABBOTT)