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

Model Number	D087031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Two devices were reported that were involved in two separate cases.Information regarding which device belongs to which event was not provided.The first device was reported to have its tip break while inside the patient.It did not break off completely and the doctor was able to retrieve the entire catheter without any extra intervention.No injuries were reported.The second device was reported to have its tip break upon insertion.No injuries were reported.
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2022 of a report from (b)(6) medical center on two viewflex xtra ice devices that were involved in two separate cases.Information regarding which device belongs to which event was not provided.Both events are being reported, refer to 3011610434-2022-00001.Per the feedback received from the hospital, the first device was reported to have its tip break while inside the patient.It did not break off completely and the doctor was able to retrieve the entire catheter without any extra intervention.No injuries were reported.The second device was reported to have its tip break upon insertion.No injuries were reported.Innovative health received the device for evaluation on (b)(6) 2022.Upon investigation, the fracture on the device was confirmed.The tip did not fall off completely and was attached to the shaft.

• Brand Name: NA
• 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: giancarlo montiel ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 13694537
• Report Number: 3011610434-2022-00002
• Device Sequence Number: 19309191
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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: 06/14/2022
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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