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	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2026, it was reported that there was a faulty bleed-back valve.There were no adverse patient consequences as a result of this event.Innovative health received the device for investigation on (b)(6) 2026.A visual inspection was performed upon the dilator and introducer sheath upon receipt.The hemostasis tubing was partially torn/cut from the valve housing.No other damage or defects were noted on the returned introducer or dilator.Leak testing was performed on the device and the device was found to fail leak testing.The process control record was reviewed to ensure that all manufacturing and inspection process steps were performed and no anomalies were noted.Based on the visual inspection results, the reported issue of a "faulty bleed-back valve" could not be confirmed, however, due to the tear/cut in the hemostasis tubing and the failed leak, test, it can be confirmed that there were performance issues with the reprocessed agilis sheath.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
On (b)(6) 2026, it was reported that the device had to be exchanged due to a faulty bleedback valve.Upon receipt of the device, there was a small cut on the hemostasis tubing near the hub.

• 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: 24839822
• Report Number: 3011610434-2026-00007
• Device Sequence Number: 6026990
• 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): 04/10/2026

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: 03/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2026
• 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