MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HEARTSPAN; TRANSSEPTAL NEEDLE KIT AND STYLET

Catalog Number FND-025-01/A

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

Patient Problem Pericardial Effusion (3271)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record and complaint database cannot be performed as the lot number was not provided.

Event Description

Customer alleges during procedure the patient experienced pericardial effusion.The patient did receive medical intervention and prolonged hospitalization.

• Brand Name: HEARTSPAN
• Type of Device: TRANSSEPTAL NEEDLE KIT AND STYLET
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 18803755
• MDR Text Key: 336505847
• Report Number: 3010665433-2024-00009
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: FND-025-01/A
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization