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

Model Number	00884450265604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Pleural Effusion (2010); Bronchopneumonia (2437)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
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 review of the device history and complaint database were performed; there were no exception documents found and there were no other complaints associated with this lot.
Event or Problem Description
The account alleges that during a transseptal puncture to complete an a-fib ablation procedure, a pericardial effusion occurred.The physician had acquired access via the patient's femoral venous system with a large bore sheath and had negotiated the abdominal aorta with a guidewire and guide catheter.The transseptal needle was then inserted and positioned to align with the patient's fossa ovalis for access through and into left atrium with a coronary sinus catheter.After acquiring transseptal access [la] the patient demonstrated signs and symptoms of cardiac decompensation, pain in the lower stomach, ascites, and pleural effusion was noted.Post procedure the patient complained of exertional dyspnea [difficult or labored breathing] and vertigo, [dizziness].The patient was also administered antibiotics post procedure.The account alleges that the patient suffered from pneumonia.It is unknown if the transseptal access needle was exclusively responsible for the pleural effusion and/or other symptoms during this procedure event.

• Brand Name: TSX.FIXED CURVE BRAIDED TRANSSEPTAL SHEATH KIT
• Common Device Name: TRANSSEPTAL SHEATH KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 65 great valley parkway; malvern, pa
• MDR Report Key: 10012236
• Report Number: 2529252-2020-00009
• Device Sequence Number: 2208623
• Product Code: DYB
• UDI-Device Identifier: 00884450265604
• UDI-Public: 00884450265604
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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: 04/30/2022
• Device Model Number: 00884450265604
• Device Catalogue Number: FCL-191-02
• Device Lot Number: Q1562315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70