MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. RESOLVE®; DRAINAGE BILIARY CATHETER

Catalog Number	RBC-10-038
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that the biliary locking drainage catheter broke off within the patient during the procedure.No patient injury.
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 suspected device was returned for evaluation.Upon visual inspection, the plastic stiffener was found to be stretched and broken as reported.As the device has been used, it is unable to determine whether the damage originated due to clinical use, if it became stuck or was stretched at some point.The damage may have also originated from manufacturing however, a lot number was not provided and as a result, manufacturing data is unable to be reviewed.Due to these unknowns, the true root cause is currently unknown.A medical device file search could not be performed as a lot number was not provided.

• Brand Name: RESOLVE®
• Common Device Name: DRAINAGE BILIARY CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c.
• 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: 24607638
• Report Number: 1721504-2026-00923
• Device Sequence Number: 18600359
• Product Code: FGE
• UDI-Device Identifier: 00884450313237
• UDI-Public: 00884450313237
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: RBC-10-038
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown