BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 19586736 · Received June 21, 2024

    Report

    Report Number
    3011610434-2024-00006
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 21, 2024
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    NLH
    UDI-DI
    10841898123269
    PMA / PMN Number
    K203655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAUSE AWARE ON 5-JUNE-2024 OF A REPROCESSED WEBSTER CS BI-DIRECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER REPORTED TO HAVE BEEN IN USE WHEN A CORONARY SINUS PERFORATION OCCURRED. MULTIPLE OTHER DEVICES FROM OTHER MEDICAL DEVICE MANUFACTURERS (CS EZ STEER, 8FR ACUNAV, FARAWAVE CATHETER 31 CM, PENTARAY, VERSACROSS CONNECT) WERE ALSO IN USE AT THE TIME OF THE INJURY. THE REPORTED DEVICE WAS BEING USED IN A PVI PROCEDURE AND HAD BEEN PLACED IN THE STANDARD POSITION IN THE CORONARY SINUS PRIOR TO THE PERFORATION OCCURRING. IT WAS COMMUNICATED FROM THE HOSPITAL THAT NO INTERVENTION WAS REQUIRED OF THE CARDIAC SURGEON AT THE TIME OF THE INJURY. LATER, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR OBSERVATION. A PERICARDIAL DRAIN WAS PLACED WHICH DECOMPRESSED THE TAMPONADE. THE PATIENT REMAINED IN THE OR UNTIL STABLE, WHICH WAS CONFIRMED THROUGH VISUALIZATION WITH CARDIAC ECHO. THE PATIENT WAS ADMITTED TO THE ICU. SEVERAL DAYS LATER, THE DRAIN WAS THEN CLAMPED AND THE TAMPONADE DID NOT REOCCUR. THE DRAIN WAS REMOVED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO DEVICE MALFUNCTIONS WERE REPORTED IN RELATION TO THE REPROCESSED WEBSTER CS BI-DIRECTIONAL CATHETER. PER INNOVATIVE HEALTH INDICATIONS FOR USE, THE REPROCESSED WEBSTER CS BI-DIRECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER IS INDICATED FOR ELECTROPHYSIOLOGICAL MAPPING OF CARDIAC STRUCTURES (I.E. STIMULATION AND RECORDING ONLY). THE CATHETER IS DESIGNED FOR USE IN THE CORONARY SINUS. THE DEVICE WAS RETURNED FOR INVESTIGATION ON 10-JUNE-2024. UPON VISUAL INSPECTION OF THE DEVICE, NO DAMAGE OR DEFECTS WERE NOTED. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. THE DEVICE PASSED ALL INSPECTION CRITERIA (ELECTRICAL, MECHANICAL, VISUAL, AND TACTILE) AT THE TIME OF MANUFACTURING AND AGAIN UPON COMPLAINT INVESTIGATION. THEREFORE, WITH THE INFORMATION AVAILABLE, INNOVATIVE HEALTH CANNOT CONFIRM THAT THERE WERE PERFORMANCE ISSUES WITH THE REPROCESSED WEBSTER CS BI-DIRECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER.

    Description of Event or Problem · 0

    A REPROCESSED WEBSTER CS DEVICE WAS REPORTED TO HAVE BEEN USED DURING A PROCEDURE THAT RESULTED IN A CORONARY SINUS PERFORATION. SEVERAL DEVICES FROM OTHER MEDICAL MANUFACTURERS WERE ALSO IN USE AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204105 N/A DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER NLH INNOVATIVE HEALTH, LLC. BD710DF282RTS 10841898123269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R