MAUDE Adverse Event Report: MERIT MEDICAL IRELAND, LTD INQWIRE®; WIRE, GUIDE, CATHETER

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/20/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device is not available for evaluation.A review of the product history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.
Event or Problem Description
It was reported that during pfa procedure, after performing the transseptal puncture using an nrg radiofrequency needle, an exchange over a guidewire was carried out with a non-merit faradrive sheath, and a non-merit farawave catheter was inserted according to instructions.Once the left atrial mapping was completed, pfa erogations were performed in the pulmonary veins and on the posterior wall.A drop in blood pressure and cyanosis of the patient's face were observed during procedure.Cardiac tamponade was suspected due to the presence of pericardial effusion confirmed by echocardiography.Resuscitation procedures and pericardiocentesis were performed.The patient subsequently experienced multiple episodes of ventricular fibrillation/electromechanical dissociation.The energy deliveries by the non-merit farawave nav catheter never recorded errors 301 or 303 and devices flushing procedures were carried out correctly.The physician considered the complications and subsequent patient death to be caused or contributed to by the procedure itself and not the device.

• Brand Name: INQWIRE®
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL IRELAND, LTD; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer (Section G): MERIT MEDICAL IRELAND, LTD; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer Contact: lisa perz rn, msn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 25552866
• Report Number: 9616662-2026-00024
• Device Sequence Number: 21520443
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K133230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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 Catalogue Number: IQ35F180J1O5RS/B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown