MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HEARTSPAN TRANSSEPTAL NEEDLE; TRANSSEPTAL TROCAR

Catalog Number FND-020-01/B

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during an a-fib procedure, while under general anesthesia, during the mapping phase, the anesthesiologists noticed a depreciation of the vital parameters, such as blood pressure drop.The transesophageal echo showed fluid in the pericardium, thus a pericardiocentesis was performed for draining the blood.As the fluid drained, it was concluded that open chest surgery was needed for the bleeding to be stopped.The patient was transferred to the or and the surgeons found a perforation in the left atrial appendage (laa).The patient was transferred to the icu post-op.No additional patient consequence to report.

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
• Type of Device: TRANSSEPTAL TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 13656743
• MDR Text Key: 287403963
• Report Number: 3010665433-2022-00020
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450489437
• UDI-Public: 884450489437
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: N/A
• 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: 02/23/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FND-020-01/B
• Device Lot Number: E2205473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention