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

Model Number	D087031
Medical Device Problem Codes	Fracture (1260); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health became aware on 16-jul-2025 of a report of a reprocessed viewflex xtra ice diagnostic ultrasound catheter that was bent and had reported issues with the ultrasound transducer.More information was obtained from the customer and it was confirmed that the tip bent during the procedure.No patient injuries were reported.No review of the process control record was completed as the serial number of the device is unknown.The device was discarded by the facility and therefore was not returned for investigation so no further investigation into this device could be completed by innovative health.
Event or Problem Description
The devices was reported to have been received damaged and non-functioning.Two images were provided of the device, one with a fracture and one with console transducer diagnostics displayed.

• Brand Name: N/A
• Common Device Name: DIAGNOSTIC 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: 22743423
• Report Number: 3011610434-2025-00003
• Device Sequence Number: 18223334
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202042
• 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): 08/07/2025

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 Model Number: D087031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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