MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE

Model Number TCN-10

Device Problems Material Discolored (1170); Material Erosion (1214)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

Expiration date: na.

Event Description

Device analysis performed on the electrode showed that the epoxy has a red deposit, a chip out and brown-red discoloration was noted.

Manufacturer Narrative

Additional information was received that the color of a newly cured epoxy is amber or light brown.If the epoxy is subjected to too many autoclave cycles, it becomes brittle and discolored.

Event Description

Device analysis performed on the electrode showed that the epoxy has a red deposit, a chip out and brown-red discoloration was noted.

• Brand Name: NITINOL TC ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): COSMAN MEDICAL; 22 terry ave; burlington MA 01803
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6795829
• MDR Text Key: 82756537
• Report Number: 3006630150-2017-02807
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250013054
• UDI-Public: 00813250013054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: TCN-10
• Device Lot Number: 021916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1