MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 3.0; MCOT SENSOR - 3.0

Model Number	02-01846
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Heart Block (4444)
Date of Event	06/09/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2024 the patient began mcot monitoring.It was reported on (b)(6) 2024 that on (b)(6) 2024 the patient passed away and the sensor was lost by ems.The exact cause of death is unknown.It is known that the patient's husband found her, and cpr was performed.Earlier in the week on an unknown date the patient had a transcatheter aortic valve replacement (tavr) procedure and sometime post tavr procedure the patient experienced heartblock.It is unknown if the patient had history of heartblock prior to the tavr procedure.Outside of the tavr procedure the patient's medical history is unknown.
Additional Manufacturer Narrative
It was reported that the patient expired post tavr procedure.The device was not returned for device evaluation.Evaluation was unable to be performed as the device was not returned or is unable to be recovered.Engineering evaluation was unable to be performed as the device was not returned.He sensor was scrapped into mrb lost.Pt family stated that the device was lost when the paramedics picked up the patient.No images have been provided by the patient to corroborate the allegation.There is no evidence that the sensor contributed to patient expiry.

• Brand Name: C6 SENSOR 3.0
• Common Device Name: MCOT SENSOR - 3.0
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 19711657
• Report Number: 2133409-2024-00039
• Device Sequence Number: 8541363
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Female