MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE; ELECTRODES

Model Number TCN-10

Device Problems Break (1069); Crack (1135); Material Discolored (1170); Contamination /Decontamination Problem (2895)

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

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved: model #: tcn-10 lot #: 050914, 100214, 020916, and 021816 description: nitinol tc electrode, 100 mm; model #: tcn-15 lot #: 062414 and 122815 description: nitinol tc electrode, 150 mm.

Event Description

Device evaluation performed on the returned electrodes showed that electrode lot # 050914 had discolored epoxy with a chip out.Electrode with lot #100214 had discolored epoxy and was cracked.Electrodes with lot # 123115, 021816, 062414, 020916, and 122815 are discolored and have a chip out.If the epoxy is subjected to too many autoclave cycles, the epoxy becomes brittle and discolored.

• Brand Name: NITINOL TC ELECTRODE
• Type of Device: ELECTRODES
• 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: 6845620
• MDR Text Key: 85003860
• Report Number: 3006630150-2017-03272
• 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: Physician
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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: 123115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2015
• 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