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

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported that during a cryo ablation case, a pericardial effusion was noticed in the patient.A transseptal puncture was performed using a medtronic acutus flexcath cross transseptal solution.The caller noted that a smartablate generator was in use, and no bwi ablation catheter was in use.It was noted that the only bwi product in use was the soundstar catheter.The adverse event occurred during the transseptal puncture phase.The patient's blood pressure had dropped to about 49 over 29.The pericardial effusion was confirmed and visualized in the atrium and the ventricle, via ice.Pericardiocentesis was performed, and about 800ml of fluid was removed.The caller reported that the patient is in stable condition.

Manufacturer Narrative

Pericardial effusion 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 not provided.If further information is made available a supplemental mdr will be sent.

• 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
• MDR Report Key: 19184420
• MDR Text Key: 341073070
• Report Number: 3012120746-2024-00006
• 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: BIOSENSE WEBSTER SMARTABLATE RF GENERATOR; BIOSENSE WEBSTER SOUNDSTAR ULTRASOUND CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention