BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INQUIRE

    MDR report key: 20086452 · Received August 28, 2024

    Report

    Report Number
    2124215-2024-51986
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    August 8, 2024
    Report Date
    September 25, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS INC
    Product Code
    DQX
    UDI-DI
    10884450019464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR FOR THIS EVENT WAS SENT IN ERROR, AS THE DEVICE RESPONSIBLE FOR THE ADVERSE EVENT WAS INITIALLY MISIDENTIFIED AS THE IQ MARKER WIRE MANUFACTURED BY BOSTON SCIENTIFIC. THE CORRECT DEVICE IS THE INQUIRE GUIDEWIRE MANUFACTURED BY MERIT MEDICAL SYSTEMS INC. REPORTING RESPONSIBILITY FOR THE INQUIRE GUIDEWIRE BELONGS TO MERIT MEDICAL SYSTEMS INC, NOT BOSTON SCIENTIFIC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PERFORATION OCCURRED. THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION AND HAD A TINY EFFUSION WHICH DID NOT CONCERN THE PHYSICIAN. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV). VASCULAR ACCESS WAS OBTAINED USING A TRANSSEPTAL APPROACH. A FARAPULSE CATHETER WAS INTRODUCED, AND A 185 CM IQ MARKER GUIDEWIRE WAS STEERED TO WIRE THE LSPV BUT INSTEAD WIRED THE APPENDAGE. THE IQ WIRE WAS PULLED BACK TO STEER TO THE CORRECT LOCATION, BUT THE APPENDAGE WAS AGAIN WIRED. THE WIRE WAS QUICKLY PULLED AND FELL INTO THE LSPV. THE LEFT ATRIAL PRESSURE IMMEDIATELY BEGAN TO TANK VERY RAPIDLY, FROM 100 TO 60. INTRACARDIAC ECHOCARDIOGRAPHY REVEALED A LARGE EFFUSION, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. ANOTHER PHYSICIAN ARRIVED AND IMMEDIATELY BEGAN PERICARDIOCENTESIS. TWO BAGS WERE FILLED, AND THE PATIENT WAS STILL BLEEDING. THE SURGICAL BACKUP TEAM WAS CALLED AND WAS ON STANDBY. THE EFFUSION WAS DRAINED WITH A BAG AND AFTERWARD THE PATIENT REMAINED STABLE. THE PHYSICIAN THOUGHT THE WIRE MUST HAVE PERFORATED THE APPENDAGE. THE PROCEDURE WAS NOT COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PERFORATION OCCURRED. THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION AND HAD A TINY EFFUSION WHICH DID NOT CONCERN THE PHYSICIAN. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV). VASCULAR ACCESS WAS OBTAINED USING A TRANSSEPTAL APPROACH. A FARAPULSE CATHETER WAS INTRODUCED, AND AN INQUIRE GUIDEWIRE WAS STEERED TO WIRE THE LSPV BUT INSTEAD WIRED THE APPENDAGE. THE GUIDEWIRE WAS PULLED BACK TO STEER TO THE CORRECT LOCATION, BUT THE APPENDAGE WAS AGAIN WIRED. THE WIRE WAS QUICKLY PULLED AND FELL INTO THE LSPV. THE LEFT ATRIAL PRESSURE IMMEDIATELY BEGAN TO TANK VERY RAPIDLY, FROM 100 TO 60. INTRACARDIAC ECHOCARDIOGRAPHY REVEALED A LARGE EFFUSION, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. ANOTHER PHYSICIAN ARRIVED AND IMMEDIATELY BEGAN PERICARDIOCENTESIS. TWO BAGS WERE FILLED, AND THE PATIENT WAS STILL BLEEDING. THE SURGICAL BACKUP TEAM WAS CALLED AND WAS ON STANDBY. THE EFFUSION WAS DRAINED WITH A BAG AND AFTERWARD THE PATIENT REMAINED STABLE. THE PHYSICIAN THOUGHT THE WIRE MUST HAVE PERFORATED THE APPENDAGE. THE PROCEDURE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127449 INQUIRE WIRE, GUIDE, CATHETER DQX MERIT MEDICAL SYSTEMS INC 2502-21 10884450019464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H