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

Model Number	D087031
Medical Device Problem Codes	No Display/Image (1183); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on 3/31/2023 of a viewflex xtra ice device from (b)(6) center reported to have a "bent tip, no signal".Innovative health received the device for evaluation on 3/31/2023.Upon investigation, the fracture on the device was confirmed.The tip did not fall off completely and was attached to the shaft.The fractured tip likely contributed to the no signal reported.No injury was reported.
Event or Problem Description
The device was reported to have a bent tip and no signal.No patient injuries were reported.
Additional Manufacturer Narrative
Innovative health, llc became aware that the original submission contained an erroneous selection on the "outcomes attributed to adverse event" field.No patient injuries were reported associated with this event and no apparent harm occurred in relation to the reported event.

• 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: 16808926
• Report Number: 3011610434-2023-00002
• Device Sequence Number: 16910131
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 11/01/2023
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown