MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE

Model Number	TCN-15
Medical Device Problem Codes	Break (1069); Material Discolored (1170); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: na.
Event or Problem Description
A report was received that the plastic on the electrode was breaking off and coming apart.
Additional Manufacturer Narrative
Device analysis confirmed that the heat shrink tubing is torn off.In addition, the epoxy has a slight bright discoloration.If the epoxy is subjected to too many autoclave cycles the epoxy becomes brittle and discolored.
Event or Problem Description
A report was received that the plastic on the electrode was breaking off and coming apart.

• Brand Name: NITINOL TC ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• MDR Report Key: 6654512
• Report Number: 3006630150-2017-02120
• Device Sequence Number: 13822551
• Product Code: GXI
• UDI-Device Identifier: 00813250013061
• UDI-Public: (01)00813250013061(11)120616(10)120616
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 05/25/2017

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-15
• Device Lot Number: 120616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1