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

Catalog Number	FND-025-01/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the investigation is complete.
Additional 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
• Common Device Name: 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
• Report Number: 3011642792-2023-00057
• Device Sequence Number: 17779885
• Product Code: DRC
• UDI-Device Identifier: 00884450451717
• UDI-Public: 884450451717
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: FND-025-01/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown