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

Model Number	10135910
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2023 of an acunav diagnostic ultrasound catheter from st luke's hospital of kansas city reported to have particulates on the handle.The particulates were noticed after the device entered the patient.The device was then removed from the patient and the physician ordered 2g ancef to be administered to the patient as the catheter had entered the body momentarily.No injuries were reported.Innovative health received two acunav devices for investigation on 5/4/2023, and the serial number was assessed to be either (b)(6) or (b)(6).See 3011610434-2023-00009 for the associated report for the other returned acunav device.Upon investigation, the device handle was confirmed to have particulates suspected to have originated from the device packaging.
Event or Problem Description
This device was reported to have a dust/powder on the handle.This was noticed after the device entered the patient.The device was then removed from the patient and the physician ordered 2g ancef to be administered to the patient as the catheter had entered the body momentarily.No injuries were reported.

• Brand Name: N/A
• Common Device Name: DIAGOSTIC 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: 17011434
• Report Number: 3011610434-2023-00008
• Device Sequence Number: 7555048
• Product Code: OWQ
• UDI-Device Identifier: 10841898110115
• UDI-Public: 10841898110115
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153090
• 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): 05/26/2023

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 Model Number: 10135910
• Device Catalogue Number: 10135910
• 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: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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