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

Model Number	900304
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question is not available for investigation at the time of this submission, and therefore, an investigation has not yet been completed.Per follow-up with the representative, the guidewire was in the left atrium, and while moving the flexcath sheath into the left atrium, the wire may have moved to the left atrial appendage and managed to puncture/poke a hole, causing an effusion.This was not visualized and it is unknown if this is the exact cause of the event.A supplemental report will be submitted with additional information once available.
Event or Problem Description
It was reported that pericardial effusion was observed after the transseptal puncture was performed during a cryo ablation procedure.The patient was under general anesthesia and was given heparin before the transseptal puncture.The pericardial effusion was noted just after the completion of the transseptal puncture.A pericardial tap was performed to address the issue and the anticoagulant (heparin) was reversed.The case was aborted and the patient was moved to the intensive care unit (icu) for observation.The patient's hospitalization was extended.The patient responded well to the pericardial tap and no further complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction/corrective data: section d9: the device in question was available for evaluation and returned to manufacturer.Section h3: device was returned to manufacturer and evaluated section h6: coding for type of investigation (changed from 4114 to 3331) , investigation findings (from 3233 to 3221) , investigation conclusions (from 11 to 4315).Device evaluation: the device in question was returned and evaluated.Investigation could not be performed on the alleged guidewire.It is not possible to test whether the guidewire caused or contributed to the adverse event.No root cause could be established for this complaint.No non-conformances were noted per device history record review.

• Brand Name: ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE
• Common Device Name: 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 bennet ; 2210 faraday ave; suite 100; carlsbad, CA 92008 ; 4422326031
• MDR Report Key: 18531263
• Report Number: 3012120746-2024-00001
• Device Sequence Number: 17837488
• Product Code: DRE
• UDI-Device Identifier: 00850027837826
• UDI-Public: (01)00850027837826(11)230914(17)250912(10)104998
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 09/12/2025
• Device Model Number: 900304
• Device Lot Number: 104998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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: FLEXCATH STEERABLE SHEATH (4FC12)
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown