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

Model Number	401932
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This device's steering mechanism was reported to fail and would not straighten.
Additional Manufacturer Narrative
Innovative health, llc became aware on 08-jul-2022 of a report from stormont vail health on a livewire steerable device that experienced a failure of the steering mechanism while inside the patient and would not straightener to remove.Innovative health received the device for evaluation on 20-jul-2022.Upon investigation, the shaft of the device was found to be separated from the handle of the device.Additional details were received on 28-jul-2022 indicating that this separation was performed by the doctor in an attempt to straighten the catheter.The steering mechanism of the reported device was manipulated and could fully rotate as intended.The puller wire of the reported device was able to extend and retract from the handle as expected.As the handle and shaft were disconnected, the distal curve of the device could not be evaluated.Additional investigation was performed in an attempt to replicate the reported issue.A root cause for this reported issue was unable to be determined.No injury was reported.

• Brand Name: N/A
• Common Device Name: DIAGNOSTIC EP 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: 15156950
• Report Number: 3011610434-2022-00009
• Device Sequence Number: 5208262
• Product Code: NLH
• UDI-Device Identifier: 10841898111808
• UDI-Public: 10841898111808
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 05/08/2024
• Device Model Number: 401932
• Device Catalogue Number: 401932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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