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

Model Number 00884450160923

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

Patient Problem Pericardial Effusion (3271)

Event Date 08/11/2021

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 customer alleges that during the transeptal puncture, the provider noticed a small pericardial effusion after few attempts to make the transeptal cross.As soon the physician reviewed the tee, to ensure the patient safety, he decided to cancel the procedure.The patient was transferred to intensive cardiac unit for close monitoring with out any other issue and in good condition.

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
• Type of Device: TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 12576876
• MDR Text Key: 274749512
• Report Number: 3010665433-2021-00088
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450160923
• UDI-Public: 00884450160923
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00884450160923
• Device Catalogue Number: FND-025-02/A
• Device Lot Number: E2157785
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention