MAUDE Adverse Event Report: MERIT MEDICAL IRELAND, LTD. INQWIRE®; CARDIAC CATHETER GUIDEWIRE, SINGLE-USE

Catalog Number	IQ35F180J1O5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	01/15/2026
Type of Reportable Event	Death
Event or Problem Description
The account alleges that a faraview procedure was performed without imaging guidance.During the procedure, no device malfunction or specific intra-procedural issues were reported; however, difficulty accessing the left veins was noted, requiring multiple guidewire insertion attempts.No abnormalities were identified on echocardiography at the conclusion of the procedure.Several hours post-procedure, the patient developed clinical deterioration, and echocardiography identified cardiac tamponade with pericardial effusion.A thoracic drain was placed, resulting in temporary clinical improvement.Later that night, the patient experienced recurrent tamponade requiring emergent open-chest surgical intervention.Intraoperative findings identified damaged tissue beneath the left pulmonary veins, suspected to be the source of pericardial effusion and tamponade.No discrete perforation or defect of a specific device was identified.The tamponade was assessed as procedure-related; however, a direct causal association to a specific medical device could not be established.The patient required hospitalization beyond standard post-procedure care and ultimately died.
Additional Manufacturer Narrative
The suspect device was not returned 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.Nonconformance's of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: INQWIRE®
• Common Device Name: CARDIAC CATHETER GUIDEWIRE, SINGLE-USE
• Manufacturer (Section D): MERIT MEDICAL IRELAND, LTD.; parkmore business park west; ballybrit, galway H91W2 74; EI H91W274
• Manufacturer (Section G): MERIT MEDICAL IRELAND, LTD.; parkmore business park west; ballybrit, galway H91W2 74; EI H91W274
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 24199370
• Report Number: 1721504-2026-00842
• Device Sequence Number: 15868543
• Product Code: DQX
• UDI-Device Identifier: 00884450056295
• UDI-Public: 00884450056295
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K002289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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: IQ35F180J1O5
• 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: 01/16/2026
• Initial Report FDA Received Date: 01/28/2026
• 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