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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Thrombus/thrombosis is a potential clinical risk associated with the flexcath cross device, which is the same as the risk of a procedure performed with similar, competitive devices.No further information is available as reporter contact information was provided.If further information is made available a supplemental mdr will be sent.

Event Description

During a cryo ablation procedure, a clot formed in the left atrium.Patient was brought into the room for the procedure.Patient was positioned on table.Ensite x patches applied per ifu.Anesthesia completed prep and intubation.Patient was prepped and draped in usual manner.Local anesthesia to right and left groin.Multiple access sites obtained and diagnostic catheters (abt - supreme quad / inquiry quad / viewflex xtra) positioned in the his, rv and ra sites.Baseline act obtained and result was 170 secs.Mdt cryo balloon / mdt achieve catheter prepped and inserted into la.Ensite x system final setup completed per ifu.La geometry and pre-ablation voltage mapping started.Act drawn.Clot visualized on ice and consult called which confirmed clot formation on ice.Act result was 310 sec.To remove the clot, negative pressure was applied to the mdt flexcath sheath as the mdt cryo balloon and mdt achieve catheter were slowly withdrawn into the sheath and removed from the la.Access sites attended to by lab staff.Protamine was not administered.Act drawn.Act result was 279 sec.No additional complications were demonstrated.The patient was extubated and sent to post-procedure recovery.

• Brand Name: FLEXCATH CROSS
• Type of Device: INTEGRATED NEEDLE/DILATOR
• 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: 19184468
• MDR Text Key: 341073338
• Report Number: 3012120746-2024-00007
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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: ABBOTT INQUIRY QUADRIPOLAR CATHETER; ABBOTT SUPREME QUADRIPOLAR CATHETER; ABBOTT VIEWFLEX XTRA ICE CATHETER; MEDTRONIC ACHIEVE MAPPING CATHETER; MEDTRONIC CRYOBALLOON; MEDTRONIC FLEXCATH SHEATH
• Patient Outcome(s): Required Intervention