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

Catalog Number	IQ35F150J3/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports during a procedure to treat atrial fibrillation an inqwire guidewire was used.A pericardial effusion was noted after the volt pfa catheter was introduced into the left atrium.One ablation (in lspv) was attempted and canceled due to a continued drop in left atrial pressure, at which time a pericardial effusion was identified via viewflex ice catheter.A pericardiocentesis was performed, and the case was subsequently aborted.At the time of the event, the volt catheter, non-abbott device (merit inqwire guidewire), and 13 fr agilis sheath were present in the patient.The exact source of the perforation remains unknown, though the merit inqwire nor the transseptal puncture which was performed using non-abbott device (versacross by boston scientific) could not be excluded as a potential contributing factors.The patient is hemodynamically stable and currently recovering appropriately.There were no performance issues with any device.
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 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.

• 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: 50800776
• Report Number: 9616662-2026-00049
• Device Sequence Number: 18794327
• Product Code: DQX
• UDI-Device Identifier: 00884450005156
• UDI-Public: 00884450005156
• 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: Other,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: IQ35F150J3/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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• 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