MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC. N/A; INTRAVASCULAR ULTRASOUND CATHETER

Model Number	85900P
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc became aware on (b)(6) 2025 of a reprocessed eagle eye platinum rx digital ivus catheter reported to be "separated".No injuries or other clinical signs/symptoms were reported.A review of the process control record was performed and no anomalies were noted.Innovative health received the device for investigation on (b)(6) 2025.The device was visually inspected and the tip was confirmed to be separated from the device.The tip was not returned along with the device for investigation.Deformation of the device shaft and transducer was also noted.The inner connector wires were found to be completely cut near the device transducer.Additional information was requested from the facility related to the usage of this device and no information was provided to innovative health.
Event or Problem Description
On (b)(6) 2025, the device was returned with a note stating, "catheter separated".No further details were provided.

• Brand Name: N/A
• Common Device Name: INTRAVASCULAR ULTRASOUND CATHETER
• 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: 21653301
• Report Number: 3011610434-2025-00001
• Device Sequence Number: 9371969
• Product Code: OWQ
• UDI-Device Identifier: 10841898131349
• UDI-Public: 10841898131349
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K210655
• 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): 03/20/2025

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: 01/29/2026
• Device Model Number: 85900P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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