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

Model Number	G408324
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 29-jan-2026, innovative health became aware of a reprocessed agilis nxt steerable introducer reported to have leaking out of the valve once the sheath was placed into the body, unacceptable maneuverability, and there were bubbles in the line.There were no patient consequences reported as a result of this event.A review of the process control record was performed to ensure that each manufacturing and inspection operation was performed and no anomalies were noted.The device met all inspection criteria at the time of manufacturing.As the device met all inspection criteria prior to distribution and an investigation into the physical device was not able to be completed, innovative health cannot confirm whether there were any performance issues with the reprocessed sheath.The cause of the reported event could not be conclusively determined.
Event or Problem Description
The device was reported to have leaking out of the sheath once it was placed into the body.The maneuverability of the sheath was reported to be unacceptable, and there were bubbles reported to be in the line.

• 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: 24476368
• Report Number: 3011610434-2026-00003
• Device Sequence Number: 13156970
• Product Code: PNE
• UDI-Device Identifier: 10841898120282
• UDI-Public: 10841898120282
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/27/2026

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: G408324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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