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

Model Number G408321

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307207716
• Report Number: 3011610434-2022-00012
• Device Sequence Number: 1
• Product Code: PNE
• UDI-Device Identifier: 10841898128196
• UDI-Public: 10841898128196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1