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

Catalog Number FND-025-02

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  Injury  

Event Description

The account alleges that during a pulmonary vein isolation procedure for a patient dx with a-fib.A pericardial tamponade occurred during the transseptal puncture attempt from the right atrium to the left atrium.The patient had a challenging heart anatomy limiting the septal targets.The patient's aorta was large and was pushing against the right atrial wall, so after the puncture attempt, the patient's blood pressure started to drop.After performing a tee, the physician confirmed the patient was experiencing pericardial tamponade.A pericardiocentesis was urgently performed.When the patient was hemodynamically stable, the patient was transferred to a recovery room for continued observation and extended hospitalization.No additional patient consequences to report.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.

• Brand Name: HEARTSPAN®.TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18655609
• MDR Text Key: 334722844
• Report Number: 3011642792-2024-00012
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FND-025-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/06/2024
• 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
• Treatment: INTERVENTIONAL TRANSEPTAL CATHETER; WEBSTER CS THERMOCOOL CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening