MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO RESOLVE LOCKING DRAINAGE CATHETER

Catalog Number	RLC-8-038MB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that a patient had an 8.5fr resolve drainage catheter placed on an unknown date.The patient returned for a catheter exchange on (b)(6) 2024.During removal of the resolve drain it was noted to not be intact.The physician removed three separate pieces of the drain which then was able to confirm entire drain was retrieved.
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 device history record and complaint database could not be performed as a lot number was not provided.

• Brand Name: RESOLVE LOCKING DRAINAGE CATHETER
• Common Device Name: DRAINAGE CATHETER
• 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: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20300491
• Report Number: 3011642792-2024-00066
• Device Sequence Number: 20730090
• Product Code: GBX
• UDI-Device Identifier: 00884450362976
• UDI-Public: 00884450362976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: RLC-8-038MB
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown