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

Model Number	D135304
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc became aware on 8-oct-2024 of a reprocessed webster cs uni-directional diagnostic electrophysiology catheter reported that "it looks like the cable might have gotten stuck in the catheter and the connector broke upon removal".No injuries or clinical signs/symptoms were reported.A review of the process control record was performed and no anomalies were noted.Innovative health received the device for investigation on 29-oct-2024.The device was visually inspected and the connector was confirmed to be partially detached from the device handle.The connector was not completed detached and remained connected to the handle via the internal wiring.No additional damage or defects were noted on the device.The pins in the connector were inspected and were found to be in good condition.The cable reported to have gotten stuck in the catheter was not returned along with the device for investigation.It is unknown whether or not this cable was reprocessed by innovative health.
Event or Problem Description
On (b)(6) 2024, it was reported that it looks like the cable might have gotten stuck in the catheter and the connector broke upon removal.

• 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: 20570665
• Report Number: 3011610434-2024-00010
• Device Sequence Number: 20857067
• Product Code: NLH
• UDI-Device Identifier: 10841898125409
• UDI-Public: 10841898125409
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/30/2024

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: 02/07/2025
• Device Model Number: D135304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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
• Patient Sex: Unknown