MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC.; STEERABLE INTRODUCER

Model Number	408310
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on 04-mar-2022 of a report from (b)(6) on a agilis nxt device that experienced air bubbles in its sideport 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 air bubbles were noticed.Multiple attempts were made to gather more information regarding the event; however, information was unavailable.The device was unable to be evaluated and no results were able to be obtained.No injury was reported.
Event or Problem Description
The sideport of this device was reported to have air bubbles midway through the procedure while connected to a transducer.The tip of this device was in the left atrium when the physician flushed the sheath, resulting in air bubbles being noticed again after a few minutes.It was at this time that continuous flush was connected.No injuries were reported.

• Brand Name: NA
• Common Device Name: STEERABLE INTRODUCER
• 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: 13906136
• Report Number: 3011610434-2022-00005
• Device Sequence Number: 4277300
• Product Code: PNE
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170311
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

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 Model Number: 408310
• Device Catalogue Number: 408310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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