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

Model Number	G408320
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The device was reported to have a hemostatic valve that was back flowing.
Additional Manufacturer Narrative
On (b)(6) 2026, it was reported that the hemostatic valve was back flowing.No adverse patient effects were reported as a result of the event.Upon receipt of the device for investigation on (b)(6) 2026, it was noted during visual inspection that there was damage to the valve as well as the hemostasis tubing was partially detached from the hub.The tubing was only partially detached from the hub and remained attached to the device.No other damage or defects were noted on the returned device.A review of the process control record was performed 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 is able to be confirmed.As the device met all inspection criteria at the time of manufacturing, the cause of the reported event could not be conclusively determined.

• 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: 24839552
• Report Number: 3011610434-2026-00006
• Device Sequence Number: 6012053
• Product Code: PNE
• UDI-Device Identifier: 10841898128172
• UDI-Public: 10841898128172
• Combination Product (Y/N): N
• 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: G408320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2026
• 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