MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. TSX¿ FIXED CURVE BRAIDED TRANSSEPTAL SHEATH; TXSSHEATH

Catalog Number	FCL-191-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	11/02/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device will not be returning to the manufacturer for evaluation.A lot number was reported, and a review of the manufacturing history record is currently in progress.
Event or Problem Description
The account alleges that during a left atrial appendage closure [laac] procedure the operating physician experienced complications with a steerable sheath.It is alleged that "device issues" may have caused or contributed to patient complications during the procedure.The account alleges that "the attending physician needed to reposition the steerable sheath repeatedly throughout the procedure".The patient experienced a possible "leak" [pericardial effusion] that may have led to possible cardiac tamponade on the left atrial appendage side.A code was activated, and hospital protocols were initiated in attempts to stabilize the patient.The laa closure device was successfully deployed during this procedure.The patient expired on (b)(6) 2021.No additional information about this event has been provided to merit medical by the account.A good faith effort of 3 or more attempts to collect additional information regarding this event has been successfully completed by the manufacturer in a timely manner.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TSX¿ FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
• Common Device Name: TXSSHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley pkwy; malvern PA 19355
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12902228
• Report Number: 2032338-2021-00014
• Device Sequence Number: 4956050
• Product Code: DYB
• UDI-Device Identifier: 00884450265598
• UDI-Public: 884450265598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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: Health Professional
• Device Expiration Date: 07/13/2023
• Device Catalogue Number: FCL-191-01
• Device Lot Number: Q1865264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE.; TRANSEPTAL NEEDLE.
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown