MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC.; 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	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This device was reported to have its image go black just before going transseptal.Another device was able to be used without issue.Investigation of the returned device identified a fractured tip and a kink on the shaft.No patient injuries were reported.
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2022 of a report from chippenham hospital on a viewflex xtra ice device where the image went black during a procedure right before going transseptal.Innovative health received the device for evaluation on (b)(6) 2022.Upon investigation, the distal tip of the device was found to be fractured.The tip did not fall off completely and was attached to the shaft.Furthermore, the a kink was noted on the shaft of the device.The fractured tip likely contributed to the black image noted in the initial report.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: 15831015
• Report Number: 3011610434-2022-00015
• Device Sequence Number: 5072178
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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: 05/05/2023
• Device Model Number: D087031
• Device Catalogue Number: D087031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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
• Patient Sex: Unknown