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

Model Number 900304

Device Problem Difficult to Advance (2920)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

The submission of this report or related information is not necessarily an admission that our employees or our device caused or contributed to the reportable event.The device in question was discarded and is therefore unavailable for investigation.No root cause could be established for this event.Supplemental mdr will be submitted if/when additional information is received.

Event Description

It was reported that after initial femoral groin access, a predialation was performed using only the dilator of the 4fc12.The dilator was inserted and retracted with no issue, over the wire provided with 900304.After that, the physician tried to advance the 900304 combined with 4fc12 over the wire and difficulty was observed.The system could not be advanced, the physician tried to perform gentle rotational movement hoping to overcome a tight spot, always under fluoro.Then the physician noticed pressurized blood flow when retracting the system.Assuming there might be arterial damage, the case was aborted.The patient received protamine to revert the initial heparin, and pressure was applied in the femoral region for around 30 minutes to stop the bleeding.There were no other reported symptoms related to this complication.

• 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 faraday ave; suite 100; carlsbad, CA 92008 ; 4422326031
• MDR Report Key: 18176083
• MDR Text Key: 328621249
• Report Number: 3012120746-2023-00011
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00850027837154
• UDI-Public: (01)00850027837154(11)230707(17)250611(10)104503
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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: 104503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• 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; Life Threatening