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

Model Number	G408321
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2022 of a report from marin general on a agilis nxt steerable introducer that was reported to not work properly.It is unknown when the issue occurred and when it was identified.Innovative health received the device for evaluation on (b)(6) 2022.Upon investigation, the side-port was identified to be detached.No injury was reported.
Event or Problem Description
This device was reported to not work properly.Upon inspection, the device was found to have a detached side-port.It is unknown when the issue was identified.No patient 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: 15629434
• Report Number: 3011610434-2022-00012
• Device Sequence Number: 7941169
• Product Code: PNE
• UDI-Device Identifier: 10841898128196
• UDI-Public: 10841898128196
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2022

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: 05/19/2023
• Device Model Number: G408321
• Device Catalogue Number: G408321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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