MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ANG SURECROSS; CATHETER, PERCUTANEOUS

Catalog Number	SC18150/C
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Event or Problem Description
It was reported that during a left lower limb angioplasty, it was noted that the radiopaque marker of the of a surecross 0.018 support catheter was moving on the surface of the catheter the physician determined it was unusable and required the opening of an additional catheter.It is reported the patient is fine.No injury or new procedure was reported.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation; however, images and videos were provided.The investigaiton involved a review of the images and videos.The complaint was confirmed.A root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The product history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: SURECROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC. ANG; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC. ANG; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 24870900
• Report Number: 3010665433-2026-00002
• Device Sequence Number: 10020081
• Product Code: DQY
• UDI-Device Identifier: 00884450187692
• UDI-Public: 00884450187692
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: SC18150/C
• Device Lot Number: E3277476
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown