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

Catalog Number	SC18150/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges during use, the 0.018 guidewire was trapped within the catheter, preventing any advancement or removal of the guidewire.While attempting to remove the guidewire, it broke into several pieces.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were identified.A review of the device history record was performed and no exception documents were found.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.A visual inspection was performed, the unit arrived in two pieces: one piece contained the hub and roughly 0.75 inches of the catheter shaft and the other piece contained the rest of the received catheter shaft.The ends of the catheter shaft pieces are elongated and kinked, consistent with the catheter undergoing some tension.No root cause was able to be confirmed.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: SURECROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23068107
• Report Number: 1721504-2025-00360
• Device Sequence Number: 9822701
• Product Code: DQY
• UDI-Device Identifier: 00884450644829
• UDI-Public: 00884450644829
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: SC18150/C
• Device Lot Number: E3056210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 01/13/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/29/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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
• Patient Sex: Unknown