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

Catalog Number	FCL-191-07
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a transeptal puncture for a left atrial appendage closure procedure, the patient experienced a drop in blood pressure and heart rate.After the first partial recapture during the procedure, pericardial effusion, hypotension, and tachycardia was noted by the attending physician.A pericardiocentesis was successfully completed approximately 1l of blood was aspirated and flushed back into the patient.Approximately thirty minutes later the patient was stable.
Additional Manufacturer Narrative
The suspect device was not returned for investigation.The description of the incident did not identify if the product was associated or expected to have contributed to this event.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be re-opened.

• Brand Name: TSX¿ FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
• Common Device Name: TRANSSEPTAL SHEATH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14781870
• Report Number: 2529252-2022-00001
• Device Sequence Number: 14897844
• Product Code: DYB
• UDI-Device Identifier: 00884450265659
• UDI-Public: 884450265659
• 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): 06/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2023
• Device Catalogue Number: FCL-191-07
• Device Lot Number: Q1881299
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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: TSX TRANSETPAL NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown