MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC N/A; DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

Model Number	7003D
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc became aware on 9-jan-2024 of a reprocessed polaris x steerable diagnostic ep catheter from sacred heart medical center at riverbend reported to have a broken tip and an exposed wire.A review of the process control record was performed and no anomalies were noted.The device passed all inspection criteria at the time of manufacturing.Innovative health received the device for evaluation on 12-jan-2024.Upon investigation, the device tip was confirmed to be deformed and the flat spring wire exposed.The entire device was returned and no missing pieces were noted.Upon evaluation of the complaint device, the steering mechanism operated as intended.The device was able to be deflected and maintain its deflection.Additional information was obtained on 22-jan-2024 from the account and no injury or complications were reported as a result of the event.
Event or Problem Description
The device was reported to have a broken tip and an exposed wire.No injuries were reported.

• Brand Name: N/A
• Common Device Name: DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
• 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: 18581068
• Report Number: 3011610434-2024-00001
• Device Sequence Number: 8491975
• Product Code: NLH
• UDI-Device Identifier: 10841898111891
• UDI-Public: 10841898111891
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

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: 03/12/2025
• Device Model Number: 7003D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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
• Patient Sex: Unknown