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

Catalog Number FND-025-01/A

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

Patient Problem Cardiac Tamponade (2226)

Event Date 08/29/2023

Event Type  Injury  

Event Description

The account alleges that during the early stages of the procedure (vascular access) a trans-esophageal-echocardiography (tee) was performed and a small pericardial effusion noted whilst the patient was in a hypertensive state.The decision was made by the treating clinician to continue the case using the tsx fixed sheath and tsx needle, on which the operator was also properly trained.The devices were inserted in order to probe the intra-atrial septum for a sufficient spot to reach the left atrium.During the probing, an increase of the formerly mentioned pericardial effusion was detected in the tee and before the passage of the septum occurred a pericardial puncture was deemed necessary by the clinician in order to mitigate the problem and return to a stable state for the patient.As per the ifu of the system, the clinician as advised that an elevated act <300sec.Had to be maintained during the entire left atrial dwell-time of the catheter and that failure to do so could potentially have a negative effect on the pericardial tamponade.The clinician decided to move forward and perform the transseptal puncture under constant tee supervision and exchanging the tsx sheath for the polarsheath without problems.During the next step of catheter preparation, outside the patient, a significant hypotension was observed which led to another examination via tee.It was found there was further volume increase of the pericardial tamponade resulting in another pericardial puncture and ultimately the cancellation of the planned pvi without the polarx ablation catheter ever being inserted in the patient.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the investigation is complete.

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 NEEDLE
• 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 ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17736019
• MDR Text Key: 323295694
• Report Number: 3011642792-2023-00057
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450451717
• UDI-Public: 884450451717
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention