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

Model Number	BD710DF282CT
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2021 of a report from iu health methodist on a webster cs bi-directional diagnostic ep catheter that presented itself with foreign material on the end of the catheter tip prior to use during a procedure.This device was not used in a procedure.The device was returned for evaluation on (b)(6) 2021.Upon receiving the device, the device was inspected, and foreign material was confirmed to be present on the device.Production records were also reviewed.The root cause is unknown.
Event or Problem Description
This device reportedly had foreign material at the end of the catheter tip.This was noticed before use during the proedure.

• 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: 12861396
• Report Number: 3011610434-2021-00021
• Device Sequence Number: 4609016
• Product Code: NLH
• UDI-Device Identifier: 10841898123290
• UDI-Public: 10841898123290
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K203655
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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
• Device Expiration Date: 10/01/2023
• Device Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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