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

Model Number	900308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while positioning the acqcross on the patient's septum to go transeptal, to place the watchman device, the patient went into heart block and then decompensated in asystole.External pacing was started as well as chest compressions until an internal pacing catheter could be placed; no effusion was seen on the transesophageal echocardiogram (tee) per the cardiologist physician.Once the pacing catheter was placed into the patient's heart, the patient returned to stable condition.An arterial line was placed in the patients left radial artery.Anesthesia was able to proceed to finish the case.The case was completed, and the watchman device was placed.Following the procedure the patient remained under monitoring on the telemetry floor and was discharged on (b)(6) 2023 in good condition.The physician believes that due to the patient anatomy, positioning of the acqcross was more difficult than usual.Additionally, the physician stated that the issue was a result of the acqcross system bumping/touching the av node on accident causing the event to occur.There was no allegation of malfunction or deficiency related to the acutus device.The device in question was discarded by the hospital and is not expected to be returned for investigation.
Additional 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.

• Brand Name: ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEDDLE
• 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 ave; carlsbad CA 92008
• Manufacturer Contact: claudia voss ; 2210 faraday ave; carlsbad, CA 92008 ; 4422326081
• MDR Report Key: 17043867
• Report Number: 3012120746-2023-00003
• Device Sequence Number: 7067667
• Product Code: DRE
• UDI-Device Identifier: 00850027837598
• UDI-Public: (01)00850027837598(11)030823(17)030625(10)104006
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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 Model Number: 900308
• Device Lot Number: 104006
• 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: 05/29/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PACING CATHETER; WATCHMAN
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG