MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. T-NEEDLE; TRANSSEPTAL NEEDLE KIT

Catalog Number TSHEATH

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

Patient Problems Perforation (2001); Cardiac Tamponade (2226); Needle Stick/Puncture (2462); Pericardial Effusion (3271)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device is not returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that during a left atrial appendage [laa] closure procedure, pericardial effusion was observed.The physician had acquired an anteroposterior projection and under fluoroscopic guidance the catheter was inserted, and advanced into the right atrium to mark the location of the aortic valve.The tip of the sheath was then positioned at the patient's fossa ovalis and the transseptal wall was punctured for left atrial access.After successfully puncturing the patient's septum, the patient became hemodynamically unstable.The physician then successfully performed a pericardiocentesis draining 120ml of blood from the patient's pericardium.The patient's status improved an hour later and the patient was then transferred to the recovery unit.

• Brand Name: T-NEEDLE
• Type of Device: TRANSSEPTAL NEEDLE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern PA 19355
• MDR Report Key: 8080872
• MDR Text Key: 127540901
• Report Number: 2529252-2018-00006
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TSHEATH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention