MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. - PEARLAND 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 expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The customer reports that during a watchman implant, the physician noticed a small pericardial effusion after few attempts to make the transeptal cross.The physician decided to cancel the procedure for patient safety.The patient was transferred to the intensive cardiac unit for close monitoring.There were no other issues and the patient is 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. - PEARLAND; 14646 kirby drive; houston TX 77047
• MDR Report Key: 12397132
• MDR Text Key: 274751435
• Report Number: 3010665433-2021-00071
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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: FND-025-02/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization