MAUDE Adverse Event Report: Merit Medical Systems, Inc. Merit Pursue¿; Intravascular microflow catheter

Catalog Number	29HC20130ST/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Merit Pursue¿
• Common Device Name: Intravascular microflow catheter
• Manufacturer (Section D): Merit Medical Systems, Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): Merit Medical Systems, Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn rn pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50830069
• Report Number: 1721504-2026-00460
• Device Sequence Number: 8542857
• Product Code: DQY
• UDI-Device Identifier: 00884450358719
• UDI-Public: 00884450358719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 29HC20130ST/A
• Device Lot Number: H3525989
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown