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

Model Number G408324

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

This device was reported to have a bleed-back valve that would not hold pressure.Blood was reported to be flowing out of the end of the agilis device until another catheter was re-inserted.No injuries were reported.The date of the event is unknown.

Manufacturer Narrative

Innovative health, llc became aware on (b)(6) 2023 of an agilis nxt steerable introducer from (b)(6) hospital reported to have a back-bleed valve that would not hold pressure.Blood was flowing out of the end of the agilis until another catheter was re-inserted.The date of the event is unknown.Innovative health received the device for evaluation on (b)(6) 2023.Upon investigation, the device hemostasis cap was identified to be insufficiently adhered to the sideport hub.No injuries were reported.

• Brand Name: N/A
• 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: rebecca sturm ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 17051772
• MDR Text Key: 317636855
• Report Number: 3011610434-2023-00010
• Device Sequence Number: 1
• Product Code: PNE
• UDI-Device Identifier: 10841898120282
• UDI-Public: 10841898120282
• 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: Other
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: G408324
• Device Catalogue Number: G408324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• 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