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	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc became aware on 4-march-2026 of a reprocessed viewflex xtra ice diagnostic ultrasound catheter reported to have bad images on ice catheter.Views were blurry.There were no allegations of any physical damage on the device in the initial report.However, upon receipt and inspection of the device on 9-march-2026, it was noted that the distal tip of the device was partially fractured.Therefore, the awareness date for the physical damage on the device was 9-march-2026, thus resulting in the submission of this report.There were no adverse patient effects as a result of the event.Upon visual inspection, the distal tip of the device was partially fractured but remained attached to the device.No further damage or defects were noted.A review of the process control record was performed to ensure that all manufacturing and inspection process steps were completed, and no anomalies were noted.
Event or Problem Description
The device was originally reported to have bad images on ice catheter.Views were blurry.Upon device receipt and inspection, the device was noted to have a fracture in the distal tip.

• 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 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 24810651
• Report Number: 3011610434-2026-00005
• Device Sequence Number: 9943968
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/07/2026

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: D087031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• 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