MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC. N/A; STEERABLE INTRODUCER

Model Number	408310
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Confusion/ Disorientation (2553)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 5-jan-2026, innovative health became aware of a reprocessed agilis nxt steerable introducer reported to have a leaky valve and air that possibly entered the patient.After going transseptal, the needle and dilator were pulled out.When the physician went to flush, he withdrew blood and saw 10 ml of air.It was initially reported on (b)(6) 2026 that the patient had a tia.Additional correspondence was obtained from the facility and reviewed on 7-jan-2026.It was confirmed that the physician did aspirate slowly and identified the alleged leak when the physician aspirated the introducer immediately after insertion.The procedure was an afib ablation in the left atrium.On (b)(6) 2026, a meeting was held with the reporting facility and the patient was reported to have been hospitalized and discharged the following day after the procedure.During the procedure, st elevation was seen on the ekg screen and the patient appeared confused after the procedure.This triggered concerns for a tia.Imaging was then performed and the tia was ruled out.The procedure was confirmed to be an afib pfa ablation using the medtronic affera system.There was no surgical intervention.A review of the process control record was performed and no anomalies were noted.Innovative health received the device for investigation on 8-jan-2026.The device was visually inspected, and no damage or defects were noted.The device met the acceptance criteria for leak testing upon investigation.Therefore, with the information available and the investigation completed, innovative health cannot confirm any performance issues with the reported introducer.
Event or Problem Description
The device was reported to have a leaky valve and air possibly entered the patient.After going transseptal, the needle and dilator were pulled out.When physician went to flush, he withdrew blood and saw 10 ml of air.The patient was initially reported to have a transient ischemic attack (tia).Additional clarifying information was provided by the facility that there was the concern of a tia, however, this was ruled out after imaging was completed.

• Brand Name: N/A
• Common Device Name: STEERABLE INTRODUCER
• Manufacturer (Section D): INNOVATIVE HEALTH, LLC.; 1435 north hayden road; suite 100; scottsdale AZ 85257
• Manufacturer (Section G): INNOVATIVE HEALTH, LLC.; 1435 north hayden road; suite 100; scottsdale
• Manufacturer Contact: rebecca sturm ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 24118439
• Report Number: 3011610434-2026-00001
• Device Sequence Number: 6075855
• Product Code: PNE
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170311
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 408310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown