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

Model Number	D-AVHD-DF16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on 12-apr-2021 of a report from (b)(6) hospital on an advisor hd grid sensor enabled high density mapping catheter.This device experienced a crack on its tip during insertion.The patient was not injured and case continued with a different device.Innovative health received the device for evaluation on 19-apr-2021.A visual inspection was performed on the returned device, and the tip was confirmed to be cracked/damaged.No further damage was identified.A tactile inspection was performed, and no bends or kinks were noted.A visual inspection of the tip straightener provided with the device was performed, and no damage was noted.
Event or Problem Description
The tip of an advisor hd grid catheter was reported to be cracked during insertion.

• 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
• MDR Report Key: 11810186
• Report Number: 3011610434-2021-00010
• Device Sequence Number: 17224401
• Product Code: NLG
• UDI-Device Identifier: 10841898130731
• UDI-Public: 10841898130731
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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: 02/19/2022
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1