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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSMAN MEDICAL NITINOL TC ELECTRODE; ELECTRODES
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COSMAN MEDICAL NITINOL TC ELECTRODE; ELECTRODES Back to Search Results
Model Number CSK-TC10-3M
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2017
Event Type  malfunction  
Event Description
The returned electrode was analyzed and visual inspection revealed traces of potting epoxy on the hub.The epoxy leaked through the shaft opening in its liquid state during the manufacturing process, and was not removed after curing.
 
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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 Key6904514
MDR Text Key87778475
Report Number3006630150-2017-03759
Device Sequence Number1
Product Code GXI
UDI-Device Identifier00813250011524
UDI-Public00813250011524
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberCSK-TC10-3M
Device Lot NumberL483
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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