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

Model Number	BD710DF282RTS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc because aware on 5-june-2024 of a reprocessed webster cs bi-directional diagnostic electrophysiology catheter reported to have been in use when a coronary sinus perforation occurred.Multiple other devices from other medical device manufacturers (cs ez steer, 8fr acunav, farawave catheter 31 cm, pentaray, versacross connect) were also in use at the time of the injury.The reported device was being used in a pvi procedure and had been placed in the standard position in the coronary sinus prior to the perforation occurring.It was communicated from the hospital that no intervention was required of the cardiac surgeon at the time of the injury.Later, the patient was taken to the operating room for observation.A pericardial drain was placed which decompressed the tamponade.The patient remained in the or until stable, which was confirmed through visualization with cardiac echo.The patient was admitted to the icu.Several days later, the drain was then clamped and the tamponade did not reoccur.The drain was removed and the patient was reported to be in stable condition.No device malfunctions were reported in relation to the reprocessed webster cs bi-directional catheter.Per innovative health indications for use, the reprocessed webster cs bi-directional diagnostic electrophysiology catheter is indicated for electrophysiological mapping of cardiac structures (i.E.Stimulation and recording only).The catheter is designed for use in the coronary sinus.The device was returned for investigation on 10-june-2024.Upon visual inspection of the device, no damage or defects were noted.A review of the process control record was performed and no anomalies were noted.The device passed all inspection criteria (electrical, mechanical, visual, and tactile) at the time of manufacturing and again upon complaint investigation.Therefore, with the information available, innovative health cannot confirm that there were performance issues with the reprocessed webster cs bi-directional diagnostic electrophysiology catheter.
Event or Problem Description
A reprocessed webster cs device was reported to have been used during a procedure that resulted in a coronary sinus perforation.Several devices from other medical manufacturers were also in use at the time of the event.

• Brand Name: N/A
• Common Device Name: DIAGNOSTIC ELECTROPHYSIOLOGY 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: 19586736
• Report Number: 3011610434-2024-00006
• Device Sequence Number: 7317921
• Product Code: NLH
• UDI-Device Identifier: 10841898123269
• UDI-Public: 10841898123269
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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 Expiration Date: 05/20/2026
• Device Model Number: BD710DF282RTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown