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

Model Number	7000D
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc became aware on (b)(6) 2024 of a reprocessed polaris x steerable diagnostic electrophysiology catheter reported to have a red/encrusted substance on the tip that would not wipe off.The catheter was used in a procedure in a fully heparinized patient.At the end of the procedure, the catheters were removed and heparin reversed with protamine.Details about the use of the device during the case are not available from the hospital.The case was completed without incident.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 investigation on 03-jun-2024.Upon investigation, the catheter was found to have red fibrous material attached to the tip.The cause of the material is not able to be determined at this time with the information available and investigation completed.
Event or Problem Description
The device was reported to have a red/encrusted substance on the tip that would not wipe off.The substance was identified after removal from the patient.The case was completed without incident.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: 19538134
• Report Number: 3011610434-2024-00005
• Device Sequence Number: 6425505
• Product Code: NLH
• UDI-Device Identifier: 10841898111877
• UDI-Public: 10841898111877
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/14/2024

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: 03/22/2026
• Device Model Number: 7000D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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