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

Catalog Number	IQ35F180J1O5RS/B
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury

• Brand Name: InQwire®
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): Merit Medical Ireland, LTD.; parkmore business park west; galway, ireland H91 W 274; EI H91 W274
• Manufacturer (Section G): Merit Medical Ireland, LTD.; parkmore business park west; galway, ireland H91 W 274; EI H91 W274
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50701998
• Report Number: 9616662-2026-00048
• Device Sequence Number: 20315153
• 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,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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
• Device Lot Number: K2887273
• 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: 08/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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