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

Model Number 408310

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

Innovative health, llc became aware on 28-sept-2023 of an agilis nxt steerable introducer from (b)(6) hospital reported to have blood flowing out from the bleed-back valve at the end of the handle upon insertion of the device.The date of the event is unknown.Innovative health received the device for evaluation on 2-oct-2023.Upon investigation, it was confirmed that blood had leaked out of the hemostasis valve.Damage was noted on the hemostasis valve.No additional damage or defects were noted on the returned sheath or dilator.No injuries were reported.

Event Description

This device was reported to have blood flowing out from the bleed-back valve at the end of the handle upon insertion of the device.No injuries were reported.The date of the event is unknown.

• 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: 17981060
• MDR Text Key: 326380978
• Report Number: 3011610434-2023-00011
• Device Sequence Number: 1
• Product Code: PNE
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 408310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2023
• 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