MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO RESOLVE® BILIARY LOCKING DRAINAGE CATHETER; LAPAROSCOPY KIT

Catalog Number	RBDC-8-038/D
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that while attempting to manipulate devices through the catheter.When attempting to remove the devices from the catheter, the components became stuck and broke off inside the catheter.The catheter and broken components were removed together.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device may be returning for a full evaluation.A supplemental report will be submitted once the evaluation is complete.A lot number was reported, and a review of the manufacturing history record is in progress.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The 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 device history record was reviewed, and no exception documents were found.
Event or Problem Description
The account alleges that while attempting to manipulate devices through the catheter.When attempting to remove the devices from the catheter, the components became stuck and broke off inside the catheter.The catheter and broken components were removed together.No additional patient consequence to report.

• Brand Name: RESOLVE® BILIARY LOCKING DRAINAGE CATHETER
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 21518943
• Report Number: 3011642792-2025-00016
• Device Sequence Number: 9560104
• Product Code: FDE
• UDI-Device Identifier: 00884450685150
• UDI-Public: 00884450685150
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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: Foreign,Consumer,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: RBDC-8-038/D
• Device Lot Number: I2884083
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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