MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC. N/A; HIGH DENSITY MAPPING CATHETER

Model Number	D-AVHD-DF16
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cheater was not able to guide the grid into the sheath.
Additional Manufacturer Narrative
Innovative health llc became aware on 27-aug-2024 of a reprocessed advisor hd grid sensor enabled high density mapping catheter reported that "the cheater was not be able to guide the grid into the sheath".Additional information was requested from the facility on 3-oct-2024 related to the use of the device within the procedure and it was reported that the catheter would not advance onto the sheath without using a great amount of force.No further information was able to be obtained.A review of the process control record was performed and no anomalies were noted.Innovative health received the device for investigation on 30-aug-2024.The device was visually inspected and deformation of the distal paddle was observed.Upon inspection, it appeared that a portion of the distal paddle insulation layer had been torn off.The insertion tool was returned with the catheter and the tool was found to have the distal end fractured.The fractured end of the insertion tool was not returned for investigation.No other damage or defects were observed.No injuries or clinical signs/symptoms were reported.Per the instructions for use: "excessive bending or kinking of the catheter may cause damage to the catheter.Do not use if the catheter appears damaged, kinked, or if there is difficulty in deflecting the distal section to achieve the desired curve.".

• Brand Name: N/A
• Common Device Name: HIGH DENSITY MAPPING 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: 20392610
• Report Number: 3011610434-2024-00008
• Device Sequence Number: 7944531
• Product Code: NLG
• UDI-Device Identifier: 10841898130731
• UDI-Public: 10841898130731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K212776
• 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): 10/07/2024

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: 05/07/2025
• Device Model Number: D-AVHD-DF16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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