MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. FLEXCATH CROSS TRANSSEPTAL SOLUTION; TRANSSEPTAL INTEGRATED DILATOR/NEEDLE

Model Number	900311
Medical Device Problem Codes	Difficult to Advance (2920); Separation Problem (4043)
Health Effect - Clinical Codes	Hematoma (1884); Retroperitoneal Hemorrhage (4483)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question has not been returned for analysis but is expected.Investigation findings and conclusions pending device analysis.
Event or Problem Description
It was reported that the patient had a retroperitoneal bleed discovered at the conclusion of the case.The physician reported the flexcath cross came unsnapped as it was advanced with the flexcath contour up the vasculature.The physician was not aware it had happened until the device had already creeped up laterally and not over the wire.At that time, the physician became aware that the guidewire (included in the packaging of the flexcath cross) had kinked.A new flexcath cross was offered and declined, but the wire was replaced with a cook amplatz 0.032j.Transeptal access was obtained via the flexcath cross/ flexcath contour without issue.Cryoablation of the pulmonary veins was completed successfully, however labile blood pressures were noted throughout the case.The retroperitoneal bleed was discovered after the sheaths had been pulled and a safe seal closure device deployed.No interventions were required and the bleed resolved on its own.However, the physician noted a significant groin hematoma.The patient's hospitalization was extended for monitoring.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Per device analysis, attempts to lock dilator into sheath were unsuccesful.The hub tib measured out of specification post use, although root cause could not be determined.No non-conformances were found after analysis of production records.Hematoma at the vascular insertion site is a potential clinical risk associated with the use of the the flexcath cross device, which is the same as the risk of a procedure performed with similar, competitive devices.It is likely that the retroperitoneal bleed/hematoma were caused by the guidewire rather than the dilator become "unsnapped" from the sheath, although follow-up information is pending from the representative.A supplemental mdr will be submitted when/if this information is received.
Additional Manufacturer Narrative
Per follow-up from representative, it is believed that the physical felt some resistance which is what prompted them to step on fluoro, as they told me "i couldn't get it to advance." at that time, the physician noticed the wire was not ahead of the sheath.They then looked at the sheath in their hands and saw the flexcath cross was no longer snapped into the sheath and had approximately 8 inches of separation from the hub of the sheath.The patient is 4'11, although there are no other notable anatomic variations.There was no defect in the guidewire noted prior to insertion into the patient.Representative stated that any explanation of how the kinking occurred while in the patient would be purely speculation.

• Brand Name: FLEXCATH CROSS TRANSSEPTAL SOLUTION
• Common Device Name: TRANSSEPTAL INTEGRATED DILATOR/NEEDLE
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; 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 ; 4422326080
• MDR Report Key: 20570877
• Report Number: 3012120746-2024-00020
• Device Sequence Number: 8170872
• Product Code: DRE
• UDI-Device Identifier: 00850027837994
• UDI-Public: (01)00850027837994(11)240104(17)260102(10)105470
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K233691
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2026
• Device Model Number: 900311
• Device Lot Number: 105470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: Not provided; 02/06/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/11/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: COOK AMPLATZ 0.032J GUIDEWIRE; FLEXCATH CONTOUR SHEATH
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown