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

Model Number 00884450265604

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Patient Problem/Medical Problem (2688); Pericardial Effusion (3271)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: TRANSSEPTAL SHEATH KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern, pa
• MDR Report Key: 10141386
• MDR Text Key: 194790179
• Report Number: 2529252-2020-00011
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00884450265604
• UDI-Public: 00884450265604
• Combination Product (y/n): N
• PMA/PMN Number: K132720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCI - WATCHMAN DEVICE.; BOSTON SCI - WATCHMAN DEVICE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention