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

Model Number	401450
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Cough (4457)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Innovative health, llc became aware on (b)(6) 2021 of a report from (b)(6) medical center on a supreme diagnostic ep catheter that was inserted down the esophagus of a patient during an ep procedure.During this time, the curve protector of the device was not taken off of the catheter and was then lodged down the patient's throat.The patient was taken back to the recovery room, where they were able to cough up the lodged curved protector.No further medical intervention was reported by the hospital.Per the feedback received from the hospital, no device malfunctions were reported with this device.This device was discarded by the hospital prior to returning the device to innovative health for evaluation.Furthermore, the device details were unavailable; thus, a review of the original manufacturing records was unable to be performed.A review of innovative health's instructions for use, ifu-ep-0008 rev.2, was performed, and the ifu states "if the catheter is packaged with a curve protector/retainer, remove and discard.".
Event or Problem Description
This device was reportedly in use down the esophagus during an ep procedure.During this time, the tip protector was not taken off of the catheter and was lodged down the patient's throat.The patient was taken back to the recovery room, where they were able to cough up the lodged tip protector.

• Brand Name: NA
• 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: 12779456
• Report Number: 3011610434-2021-00019
• Device Sequence Number: 3608198
• Product Code: NLH
• UDI-Device Identifier: 10841898114304
• UDI-Public: 10841898114304
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K182386
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 401450
• Device Catalogue Number: 401450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown