MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. RESOLVE MINI¿; CATHETER, IRRIGATION

Catalog Number	RML17-8-038MB/B
Medical Device Problem Codes	Complete Blockage (1094); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	10/27/2025
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
The account alleges that the drainage catheter became occluded.During subsequent removal, the tip injured the portal vein, causing bleeding.Surgery was performed.According to the customer, when removing the catheter, the operator did not perform the procedure to release the fixation of the suture attached to the catheter tip.However, under fluoroscopy, it was confirmed that the tip shape had straightened.No guidewire or similar device was inserted into the catheter lumen.No additional information available.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and the drainage ports contained dried debris, likely from the procedure performed.The device itself was able to be flushed with air/water, and to be straightened using a trocar.It is likely that the reason for this complaint is directly related to the use of the device.It should be noted that the ifu for this device states that a flushing regimen should be designed for the circumstances of each patient and the protocol of the physician.Root cause is unknown.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaint for this lot was identified.

• Brand Name: RESOLVE MINI¿
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23458527
• Report Number: 1721504-2025-00586
• Device Sequence Number: 15422637
• Product Code: GBX
• UDI-Device Identifier: 00884450720158
• UDI-Public: 00884450720158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 12/09/2025

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?: Yes
• Device Catalogue Number: RML17-8-038MB/B
• Device Lot Number: I3195727
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown