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	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device was reported to have a grainy image during a procedure.The catheter tip was also reported to be bent.No patient injuries were reported.
Additional Manufacturer Narrative
Innovative health, llc.Became aware on 4/28/2023 of a viewflex xtra ice device from (b)(6) reported to have a very grainy image.The catheter tip was also reported to be bent.Innovative health received the device for evaluation on 5/4/2023.Upon investigation, the fracture on the device tip was confirmed.The tip did not fall off completely and was attached to the shaft.The fractured tip likely contributed to the grainy image reported.No injury was reported.

• 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: 16942683
• Report Number: 3011610434-2023-00005
• Device Sequence Number: 11598107
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/16/2023

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: 03/09/2024
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• 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