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

Model Number	900304
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question has been discarded and is therefore unavailable for investigation.No root cause could be established for this event.No non-confirmances were noted per review of device history record.Per instructions for use if any resistance is met while advancing or withdrawing a catheter, dilator, or guidewire, determine the cause and correct it before continuing with the procedure.Supplemental mdr will be submitted if/when additional information is received.
Event or Problem Description
It was reported that during a cryo ablation procedure, resistance was noted when attempting to access the right femoral vein.The room staff were instructed on proper prep and use of the flexcath cross system.The physician was instructed on proper prep, best practices and risk mitigation when using the flexcath cross system.When attempting to access the right femoral vein with the flexcath cross system, resistance was met, and the physician continued to push force against the resistance.The physician was instructed to stop, reassess, and dilate the access site if needed.The physician noted a kink on the guidewire was present when the flexcath cross system was pulled out.The guidewire was replaced with a non-medtronic guidewire which resolved the issue.The physician dilated the access site and reinserted the flexcath cross without any further issues.Transseptal was achieved and procedure completed.A later communication was received from the hospital stating that the patient had groin complications requiring surgery.The physician was aware that the product was not a direct cause of the issue.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
**udi related data quality updates only** corrected information: d4.Incorrect primary unique device identifier (udi) # provided on initial mdr.

• Brand Name: ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE
• Common Device Name: TRANSSEPTAL 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 farday ave; suite 100; carlsbad, CA 92008 ; 4422326103
• MDR Report Key: 18187353
• Report Number: 3012120746-2023-00010
• Device Sequence Number: 6541680
• Product Code: DRE
• UDI-Device Identifier: 00850027837147
• UDI-Public: (01)00850027837147(17)250830(10)104939
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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 Expiration Date: 08/30/2025
• Device Model Number: 900304
• Device Lot Number: 104939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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: FLEXCATH STEERABLE SHEATH (4FC12)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown