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

Model Number 00884450160930

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/12/2019

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 cardiac perforation occurred during transseptal puncture for an ablation of atrial fibrilation procedure, causing cardiac tamponade.The patient underwent surgery to facilitate drainage and cardiac suture.The patient was then admitted to the intensive care unit for recovery.The physician made no notice of any problems with the device that may have contributed to the event.

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 NEEDLE/TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 65 great valley parkway; malvern PA 19355
• MDR Report Key: 9469365
• MDR Text Key: 170762104
• Report Number: 2529252-2019-00004
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450160930
• UDI-Public: 00884450160930
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 00884450160930
• Device Catalogue Number: FND-020-01
• Device Lot Number: Q1614940
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention