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

Model Number	408310
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device was reported to have valve leakage.No injuries were reported.
Additional 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.
Additional 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
• 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: rebecca sturm ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 18170145
• Report Number: 3011610434-2023-00012
• Device Sequence Number: 12665043
• Product Code: PNE
• UDI-Device Identifier: 10841898120275
• UDI-Public: 10841898120275
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 09/26/2024
• Device Model Number: 408310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown