MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE

Model Number	TCN-10-3M
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: na additional suspect medical device components involved in the event: model # tcn-10-3m lot # h735 quantity: three description: nitinol tc electrode, 100 mm, with 3m cable.
Event or Problem Description
Device analysis on three electrodes confirmed that the epoxy was very dark.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6803513
• Report Number: 3006630150-2017-03076
• Device Sequence Number: 878194
• Product Code: GXI
• UDI-Device Identifier: 00813250017502
• UDI-Public: 00813250017502
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K050084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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: Physician
• Device Model Number: TCN-10-3M
• Device Lot Number: H735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1