MAUDE Adverse Event Report: Merit Medical Ireland InQwire.Guide Wire; Wire, Guide, Catheter

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer alleged after a procedure in the electrophysiology lab, a pericardial effusion was noted on intracardiac echocardiography (ice).A peri-centesis procedure produced 150cc of fluid.An echo the next day confirmed the patient was ok and he was released.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be established.A search of the complaint database and a product history review could not be completed since no lot number was provided.

• Brand Name: InQwire.Guide Wire
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): Merit Medical Ireland; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer (Section G): Merit Medical Ireland; parkmore business park west; galway H91 W 274; EI H91 W274
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50235134
• Report Number: 9616662-2026-00069
• Device Sequence Number: 10344855
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: IQ35F180J1O5RS/B
• 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: 08/11/2026
• Initial Report FDA Received Date: 08/13/2026
• 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: Other
• Patient Sex: Unknown