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

Model Number	408310
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2026, it was reported that there was a reprocessed agilis nxt steerable introducer that after the user inserted the sheath, pulled out the dilator, the hemostasis valve started leaking.There were no adverse patient consequences as a result of this event.Innovative health llc received the device for investigation.A visual inspection was performed of the returned dilator and introducer sheath.The hemostasis value was intact and no damage or defects were noted.The hemostasis tubing had a small tear near the valve housing.The tubing remained attached to the valve housing.No other damage or defects were noted on the introducer or dilator.A review of the process control record was performed to ensure that all manufacturing and inspection process steps were completed and no anomalies were noted.Based on the visual inspection results, the reported issue is able to be confirmed as the tear in the tubing may have contributed to a leak.The reported issue of a hemostasis valve leak is unable to be replicated during complaint investigation.As the device met all inspection criteria at the time of manufacturing, the cause of the reported event could not be definitively determined.
Event or Problem Description
It was reported that after inserting the sheath, pulled out the dilator, and the hemostasis valve started leaking.

• 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 AZ 85257
• Manufacturer Contact: rebecca sturm ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 25073739
• Report Number: 3011610434-2026-00009
• Device Sequence Number: 10424878
• Product Code: PNE
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K250305
• 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): 05/04/2026

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: 04/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2026
• 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