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

Model Number 900304

Device Problem Difficult to Advance (2920)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Vascular Dissection (3160)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

No failure investigation was possible as the device was discarded.No non-conformances were noted per device history record review.A root cause could not be established in this case.

Event Description

Before the cryo examination, the across needle was presented and explained.An inguinal puncture was performed on the left groin with echo by a second specialist.There were two punctures performed.The first puncture, using an 8f with a long wire (controlled with x-ray), was followed by a second puncture for the cs catheter (also controlled with x-ray, showing intracardiac signals typical of cs).The physician threaded the prepared flex cath sheath with the loaded across onto the long wire.There were no difficulties during the skin passage at the groin area.The flex cath sheath encountered resistance about 15 cm over the wire.The physician suspected a kink in the wire and requested a change to another 32 wire for another attempt.The first wire, which had a visible kink, was discarded.The physician pulled back the flex cath sheath, switched over to a short sheath, and attempted to push the new wire back over the sheath.However, the fresh wire faced resistance and could not be advanced.Contrast medium was then administered through the short sheath.Initially it was unclear on the x-ray image where the contrast was going as the visible image remained focused on the thorax/heart area.When no contrast reached the vena cava, the physician suspected a vessel dissection.The patient's blood pressure and o2 saturation dropped.The physician punctured the left groin again, but the issue persisted.Initial medications were administered to stabilize the patient as vital signs continued to deteriorate.The case was aborted and resuscitation efforts began.Meanwhile, the emergency team, along with a vascular surgeon, were called in.The surgeon decided to operate directly in the laboratory, suspecting a long tear in the femoral vein toward the abdominal cavity.The entire sterile drape was removed and discarded; at the request of the vascular surgeon, the surgical team re-draped the patient.The patient was hospitalized for monitoring after stabilization.There were no further patient complications reported as a result of this event.All cryo material, along with the sterile material were discarded.

• 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 ; 4422326080
• MDR Report Key: 18646690
• MDR Text Key: 334613342
• Report Number: 3012120746-2024-00002
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 104769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2023
• 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): Life Threatening; Hospitalization; Required Intervention