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	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc became aware on 8-oct-2024 of a reprocessed advisor hd grid sensor enable high density mapping catheter reported that "mechanical malfunction device become stuck in the sheath upon removal and the paddle portion has damage to it".No injuries or clinical signs/symptoms were reported.A review of the process control record was performed and no anomalies were noted.Innovative health received the device for investigation on (b)(6)2024.The device was visually inspected and deformation of the distal paddle was observed.Upon inspection, the distal paddle was confirmed to be fractured in half and a portion of the distal paddle insulation layer had been torn off.The insertion tool was returned with the catheter and was found to be slightly bent out of shape.The cordis introducer used during the procedure, not reprocessed by innovative health, was returned and was observed to have damage sustained on the distal end of the sheath.No other damage or defects were observed.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.".
Event or Problem Description
On (b)(6)2024, an innovative health representative reported via email that there was a device with a mechanical malfunction, device become stuck in the sheath upon removal and the paddle portion has damage to it.

• 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: 20515945
• Report Number: 3011610434-2024-00009
• Device Sequence Number: 7081992
• Product Code: NLG
• UDI-Device Identifier: 10841898130731
• UDI-Public: 10841898130731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/23/2024

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: 02/22/2025
• Device Model Number: D-AVHD-DF16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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