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

Model Number 900304

Device Problem Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 10/19/2023

Event Type  Injury  

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 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.

• Brand Name: ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE
• Type of Device: 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
• MDR Text Key: 328741685
• Report Number: 3012120746-2023-00010
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00850027837154
• UDI-Public: (01)00850027837154(11)230921(17)250830(10)104939
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900304
• Device Lot Number: 104939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FLEXCATH STEERABLE SHEATH (4FC12)
• Patient Outcome(s): Required Intervention; Hospitalization