MAUDE Adverse Event Report: COSMAN MEDICAL CSK-TC ELECTRODE; PROBE, RADIOFREQUENCY LESION,

Model Number CSK-TC10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/22/2017

Event Type  Death  

Manufacturer Narrative

Expiration date: na.Additional suspect medical device components involved in the event: model # csk-tc10, lot # m403, description: csk tc electrode, 10cm.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that during a lumbar radiofrequency procedure, the patient passed away.The anesthesiologist noted there were some issues monitoring the patient¿s vital signs and the monitors were changed.By the time the new monitor was brought into the room, the patient did not have a heartbeat or pulse.The patient was flipped over and immediately intubated.The physician and the anesthesiologist do not know the reason for the patient¿s passing, however, they are under the impression that the patient had some sort of stroke or heart attack.The physician did not suspect any device malfunction pertaining to the patient's passing.

• Brand Name: CSK-TC ELECTRODE
• Type of Device: PROBE, RADIOFREQUENCY LESION,
• 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: 7113067
• MDR Text Key: 94692242
• Report Number: 3006630150-2017-05259
• Device Sequence Number: 1
• Product Code: GXI
• UDI-Device Identifier: 00813250010107
• UDI-Public: 00813250010107
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CSK-TC10
• Device Lot Number: M402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2017
• 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
• Patient Outcome(s): Death