MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE

Model Number	900304
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hematoma (1884); Perforation (2001)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was discarded and not returned for investigation.Root cause could not be established with the information provided.A supplemental mdr will be submitted if additional information is received.
Event or Problem Description
It was initially reported that during the procedure, the guidewire experienced a kink, leading to a subsequent kink in the sheath.Per the physician, this series of events resulted in a perforation occurring in the right common femoral vein, which in turn caused bleeding from the patient's right groin.Per follow-up, it was noted that there were no complications regarding access, which was guided by ultrasound.During the procedure, the patient reportedly coughed leading to the discovery of a hematoma in the right groin.Following the procedure, technicians applied manual pressure for a duration of 30 minutes in an attempt to manage the bleeding.A vascular surgeon was called to assist who addressed the active bleeding by utilizing sutures.Multiple access points were created in the right femoral vein to effectively halt the bleeding.After the procedure, the patient was put on bed rest for four hours and kept overnight in the hospital to be monitored.A follow-up ultrasound examination conducted on the subsequent day revealed the absence of a hematoma or pseudoaneurysm, though some bruising was observed.The patient was subsequently discharged from the clinic.

• Brand Name: ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE
• Common Device Name: TRANSSEPTAL DILATOR/NEEDLE
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday avenue; carlsbad CA 92008
• Manufacturer (Section G): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer Contact: james bennett ; 2210 faraday ave; suite 100; carlsbad, CA 92008 ; 4422326103
• MDR Report Key: 17638588
• Report Number: 3012120746-2023-00006
• Device Sequence Number: 12658782
• Product Code: DRE
• UDI-Device Identifier: 00850027837147
• UDI-Public: (01)00850027837147
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2023

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: 900304
• 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: Not provided
• Initial Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 92 KG