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	Cardiac Perforation (2513)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer has not responded to multiple attempts to retrieve additional information.Upon receipt of the following information a follow up report will be submitted.Current patient status.Age and dob: best estimate for required field was used.Patient sex: best estimate for required field was used.Patient weight: best estimate for required field was used.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 perforation.Since it cannot be determined what if any role the acutus devices may have played in this event, acutus is conservatively reporting this event.Problems with my webtrader account resulted in a late filing of this report.
Event or Problem Description
It was reported that using the acqguide max (ln101953) and acqcross max (ln102010) to go transeptal, the device moved off the septum and punctured the right atrial wall.Surgical repair was completed on the patient.There is no report or allegation of an acutus product malfunction.

• 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: 14048141
• Report Number: 3012120746-2022-00001
• Device Sequence Number: 14844757
• Product Code: DRE
• UDI-Device Identifier: 00850027837161
• UDI-Public: (01)00850027837161(11)211008(17)221008(10)102010
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 04/07/2022

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: 10/08/2022
• Device Model Number: 900305
• Device Catalogue Number: 900305
• Device Lot Number: 102010
• 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: 02/21/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 (LN101953)
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG