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	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of this device was reportedly kinked while advancing it into the heart from vein access.No patient injuries were reported.
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2021 of a report from (b)(6) hospital center on a viewflex xtra ice device that experienced a tip fracture while in use during a procedure.Per the feedback received from the hospital, this device was reported to have been inside the patient when the tip fractured.Innovative health received the device for evaluation on 26-oct-2021.Upon investigation, the fracture on the device was confirmed.The tip did not fall off completely and was attached to the shaft.No injury was reported.

• 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: robert boyd ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 12776098
• Report Number: 3011610434-2021-00020
• Device Sequence Number: 6119578
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 06/08/2022
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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