MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING HEARTSPAN TRANSSEPTAL NEEDLE KIT; TROCAR

Catalog Number FND-025-01/A

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

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 11/02/2021

Event Type  Death  

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 Description

The account alleges that during a left atrial appendage closure [laac] procedure the operating physician experienced complications with the transseptal needle kit and 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.

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: HEARTSPAN TRANSSEPTAL NEEDLE KIT
• Type of Device: TROCAR
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• 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: 12902241
• MDR Text Key: 281494225
• Report Number: 3010665433-2021-00117
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450451717
• UDI-Public: 884450451717
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Catalogue Number: FND-025-01/A
• Device Lot Number: E2085223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE.; TRANSEPTAL SHEATH.
• Patient Outcome(s): Life Threatening; Death; Life Threatening; Required Intervention; Hospitalization; Death; Required Intervention; Hospitalization