MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC.; DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

Model Number	401904
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This device was reported to be working properly during a procedure until an issue with the deflection was noted.After pulling out the catheter, the device shaft was reported to separate.The device was intact while in use, and no patient injuries were reported.
Additional Manufacturer Narrative
Innovative health, llc became aware on 4/18/2023 of a livewire device from (b)(6) hospital reported to have an issue with deflection and the device came apart outside of the patient.Innovative health received the device for evaluation on 4/26/2023.Upon investigation, the device shaft was confirmed to be separated.The material around the separation appeared to be stretched.Additionally, a fold was noted near the distal tip of the shaft.The entire device was returned, and no missing pieces were noted.Upon evaluation of the complaint device, the steering mechanism operated as intended.An evaluation of the curve and deflection was unable to be performed due to the shaft separation.No injury was reported.

• Brand Name: NA
• 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: robert boyd ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 16935253
• Report Number: 3011610434-2023-00004
• Device Sequence Number: 7291089
• Product Code: NLH
• UDI-Device Identifier: 10841898111723
• UDI-Public: 10841898111723
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190127
• 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): 05/15/2023

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: 11/02/2024
• Device Model Number: 401904
• Device Catalogue Number: 401904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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