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

Model Number	014R
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 27-oct-2025, innovative health became aware of a complaint for a reprocessed visions pv.014p rx digital ivus catheter that was reported to have the sheath of the tip sheared off, leaving the support cable visible.An image was provided of the catheter and guidewire with the guidewire stuck in the side hole.It was reported that all device components were able to be retrieved without any retained fragments in the patient.Additional information was received from the customer on 30-oct-2025 that the guidewire got stuck in the rapid exchange side hole while the physician was attempting to remove the ivus catheter over the guidewire.The catheter was damaged on the first pass and was not used again.It was reported that no patient adverse events occurred.A review of the process control record was performed and no anomalies were noted.Despite multiple attempts to retrieve the complaint device, innovative health has not yet received the complaint device.Based on the provided image in the initial complaint report, innovative health is able to confirm the noted concern.No further conclusions about the device or the potential cause of the event are available at this time with the investigation completed and information available.
Event or Problem Description
The device was reported to have the sheath of the tip sheared off, causing the support cable to be visible.It was reported that all device components were retrieved and there were no adverse patient effects.
Additional Manufacturer Narrative
Innovative health llc received the device on 24-nov-2025 for evaluation.Upon inspection, it was confirmed that there was a tear in the sheath material located where at the guidewire port.Under 20x magnification, the internal wiring and support cable were exposed as a result of the sheath tear.Therefore, the reported concern is able to be confirmed based on the results of the investigation.At this time with the information available and investigation completed, no definitive cause for the reported event is available.

• 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 n hayden rd; suite 100; scottsdale, AZ 85257
• MDR Report Key: 23639291
• Report Number: 3011610434-2025-00005
• Device Sequence Number: 21146853
• Product Code: OWQ
• UDI-Device Identifier: 10841898134418
• UDI-Public: 10841898134418
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 09/30/2026
• Device Model Number: 014R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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