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

Model Number	900305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no alleged product malfunction related to this adverse event.There were several procedure-related opportunities that may have contributed to or caused the event.The procedure itself is technically demanding and carries the risk of severe complications including pericardial effusion.However, since it cannot be determined what if any role the acutus devices may have played in this event, acutus is reporting this event to be conservative.
Event or Problem Description
It was reported that physician was performing direct transeptal puncture using acqguide max 2.0 with acqcross.Fluoroscopy looked good in multiple views once system engaged with fossa/septum.Needle deployed, however, patient quickly became unresponsive, rbbb ecg pattern and blood pressure dropped significantly.Cpr commenced while physician positioned pericardial drain under echo.Once drain in situ, patient became responsive again and blood pressure gradually improved.Blood continued to be drained from pericardium for approx.1 hour before bleeding had almost stopped.Patient transferred to ccu for monitoring at least overnight.The patient was able to return home 3 days post procedure.No product malfunction was reported as being related to this event.

• Brand Name: ACQCROSSTM QX INTEGRATED TRANSSEPTALDILATOR/NEEDLE
• Common Device Name: TRANSSEPTAL DILATOR/NEEDLE
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday avenue; suite 100; carlsbad CA 92008
• Manufacturer (Section G): ACUTUS MEDICAL, INC.; 2210 faraday avenue; suite 100; carlsbad CA 92008
• Manufacturer Contact: rita webster ; 2210 faraday avenue; suite 100; carlsbad, CA 92008 ; 4422326080
• MDR Report Key: 14088024
• Report Number: 3012120746-2022-00002
• Device Sequence Number: 5276654
• Product Code: DRE
• UDI-Device Identifier: 00850027837161
• UDI-Public: (01)00850027837161(11)210922(17)220922(10)101933
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: 09/22/2022
• Device Model Number: 900305
• Device Catalogue Number: 900305
• Device Lot Number: 101933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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: ACQGUIDE MAX SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 95 KG