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

Model Number	G408324
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 blood leaking out of the hemostasis tubing/hemostasis hub joint.
Additional Manufacturer Narrative
On (b)(6) 2026, it was reported that the hemostasis tubing/hub joint was reported to be leaking at the end of the case.Additional information was obtained from the facility at a later date and it was stated that the leaking was when the physician inserted the sheath into the body, not at the end of the case as previously reported.The hemostasis tubing was reported to be intact when removed from the packaging and was able to be flushed with no issue.There were no patient consequences reported as a result of this event.Innovative health received the device for investigation on 2-february-2026.A visual inspection was performed on the returned sheath and dilator upon receipt.The hemostasis tubing was detached from the device handle of the returned device.There was damage to the dilator hub, with a small piece of material lifting off the hub and damage to the hemostasis valves.The hemostasis hub/tubing joint was inspected, and the joint was intact however, the tubing was completely severed below the joint.Leak testing of the complaint device was not feasible due to the detached hemostasis tubing.A review of the applicable process control record was performed to ensure that each manufacturing and inspection operation was performed and no anomalies were noted.Based on the visual inspection of the returned device, and the review of the process control record, the investigation does not indicate any performance issues with the reprocessed sheath due to the reprocessing process and the cause of the reported event could not be conclusively determined.It is important to note that the ifu states, "do not remove dilator or catheter rapidly.Damage to the valve may occur, potentially compromising hemostasis.".

• 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: 24381534
• Report Number: 3011610434-2026-00002
• Device Sequence Number: 10518094
• Product Code: PNE
• UDI-Device Identifier: 10841898120282
• UDI-Public: 10841898120282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/18/2026

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 Expiration Date: 08/15/2026
• Device Model Number: G408324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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