MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. INQWIRE GUIDEWIRE

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	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that after the procedure a pericardial effusion occurred, which was promptly drained.The physician believes that the coronary sinus got perforated by the cs catheter but also stated that the complication is not a product related issue.The patient was transferred to another hospital for further surgical procedures.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record and complaint database cannot be performed as a lot number was not provided.

• Brand Name: INQWIRE GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; galway, H91 W 274; EI H91 W274
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23692644
• Report Number: 1721504-2025-00684
• Device Sequence Number: 21380497
• Product Code: DQX
• UDI-Device Identifier: 00884450019467
• UDI-Public: 00884450019467
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown