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 Date 10/26/2023

Event Type  malfunction  

Event Description

The device was reported to have valve leakage.No injuries were reported.

Manufacturer Narrative

Innovative health, llc became aware on 26-oct-2023 of a reprocessed agilis nxt steerable introducer from kaiser santa clara medical center reported to have valve leakage.No injuries were reported.Innovative health made follow-up attempts to obtain the subject device on 6-nov-2023 and 13-nov-2023 with no response.Based on the information available and not being able to complete further investigation on the subject device, innovative health cannot confirm there were performance issues with the reprocessed agilis introducer.

Manufacturer Narrative

Innovative health, llc became aware that the original submission contained an erroneous selection on the "outcomes attributed to adverse event" field.No patient injuries were reported associated with this event and no apparent harm occurred in relation to the reported event.

• 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: 18170145
• MDR Text Key: 328537738
• Report Number: 3011610434-2023-00012
• 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,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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
• Patient Outcome(s): Other