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	Patient Problem/Medical Problem (2688); Pericardial Effusion (3271)
Date of Event	05/05/2020
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 left atrial appendage closure [laac] procedure, a pericardial effusion occurred.The physician had successfully acquired access to the patients left atrium via transseptal puncture.A closure device was introduced into the left atrium -a couple of times- needing recapture due to a 5 mm gap that was appreciated.A 33 mm closure device was successfully deployed within the posterior lobe when a pericardial effusion was noted.A full recapture of the closure device was completed.The patient was in stable condition, so a new 33 mm closure device was implanted in the upper lobe.After first release of the second device, good positioning was observed.Eventually the patient's vital signs changed indicating that cardiac massage and pericardiocentesis was necessary.The patient was transferred in stable condition to surgery.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.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 KIT
• Common Device Name: TRANSSEPTAL SHEATH KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern, pa
• MDR Report Key: 10141386
• Report Number: 2529252-2020-00011
• Device Sequence Number: 3622662
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 10/28/2022
• Device Model Number: 00884450265604
• Device Catalogue Number: FCL-191-02
• Device Lot Number: Q1689511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCI - WATCHMAN DEVICE.; BOSTON SCI - WATCHMAN DEVICE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention