MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CLARIVEIN INFUSION CATHETER

Catalog Number	85-018-E140S/B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during the procedure, the device became entangled, so the physician decided to replace it.They did not notice that the catheter tip did not come out with the rest of the equipment.Subsequently, they decided to use another device to continue the procedure.Ten days later, the patient attended a follow-up appointment, reporting discomfort in the thigh.On ultrasound evaluation, the physician confirmed the presence of catheter fragments inside the vein, which were removed without complications or consequences for the patient.
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
No product returned, investigation performed usinga video provided by the customer.The video depicts the dispersion wire that should be housed within the catheter, having fractured and no longer being held within the catheter.Additionally, the distal end of the dispersion wire appears to have a significant amount of dried biomatter attached to it.The complaint could not be confirmed.The root cause could not be determined.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 identified.

• Brand Name: CLARIVEIN INFUSION CATHETER
• Common Device Name: INFUSION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22911398
• Report Number: 1721504-2025-00293
• Device Sequence Number: 21114823
• Product Code: KRA
• UDI-Device Identifier: 00884450429242
• UDI-Public: 00884450429242
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K153502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 85-018-E140S/B
• Device Lot Number: H3165069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown