MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC.; DIAGNOSTIC EP CATHETER AUTO ID

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	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on 14-nov-2022 of a report from mayo clinic - (b)(6) on a webster cs bi-directional diagnostic ep catheter auto id that was found to have fibrous material on the tip of the device.The material was identified during the procedure, before the catheter was used on the patient.Innovative health received the device for evaluation on 18-nov-2022.Upon investigation, foreign material was identified on the tip of the device.No injury was reported.Production records were also reviewed.The root cause is unknown.
Event or Problem Description
The device was reported to have fibrous material on the distal tip.No patient injuries were reported.The material was identified during the procedure, before the catheter was used on the patient.

• Brand Name: NA
• Common Device Name: DIAGNOSTIC EP CATHETER AUTO ID
• 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: giancarlo montiel ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 15882757
• Report Number: 3011610434-2022-00016
• Device Sequence Number: 12037147
• Product Code: NLH
• UDI-Device Identifier: 10841898123290
• UDI-Public: 10841898123290
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2022

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: 11/22/2023
• Device Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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