MAUDE Adverse Event Report: ACUTUS MEDICAL, INC ACQCROSS QX; ACQCROSS QX - MAX 70CM (US)

Model Number	900305-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure a cardiac tamponade occurred in the patient's left atrium while utilizing the acqguide max 2.0 sheath and acqcross max transseptal.The tamponade was slow leaking.Reportedly, the physician suspected the cause of the event was the.032 guidewire.An acutus representative made multiple attempts to obtain additional information regarding the issue however further information was unable to be obtained.
Additional Manufacturer Narrative
Acutus medical, inc.Indicated patient age as 50 since acutus medical was not provided with that information.Product was discarded and not available for evaluation.

• Brand Name: ACQCROSS QX
• Common Device Name: ACQCROSS QX - MAX 70CM (US)
• Manufacturer (Section D): ACUTUS MEDICAL, INC; 2210 faraday avenue; suite 100; carlsbad 92008
• Manufacturer (Section G): ACUTUS MEDICAL, INC; 2210 faraday ave; carlsbad 92008
• Manufacturer Contact: greg geissinger ; 2210 faraday ave; suite 100; carlsbad 92008 ; 4422326100
• MDR Report Key: 15470556
• Report Number: 3012120746-2022-00003
• Device Sequence Number: 4468657
• Product Code: DYB
• UDI-Device Identifier: 00850027837161
• UDI-Public: 00850027837161
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K210685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 900305-001
• Device Catalogue Number: 900305-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACQGUIDE MAX 2.0 SHEATH; GUIDEWIRE: .32" GUIDEWIRE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown