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

Model Number	408310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2023 of a report from (b)(6) hospital - (b)(6) on an agilis nxt steerable introducer.The device was reported to have a one way valve and hub found to be faulty during a procedure.Innovative health received the device for evaluation on 5/4/2023.Upon investigation, the hemostasis cap was identified to be detached from the sideport hub.No injury was reported.
Event or Problem Description
This device was reported to have a one-way valve and hub found to be faulty during a procedure.No injuries were reported.

• Brand Name: N/A
• 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: rebecca sturm ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 16988675
• Report Number: 3011610434-2023-00007
• Device Sequence Number: 6693741
• Product Code: PNE
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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 Expiration Date: 03/01/2024
• Device Model Number: 408310
• Device Catalogue Number: 408310
• 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: 04/26/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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