MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. RESOLVE MINI LOCKING DRAINAGE CATHETER

Catalog Number	RML17-8-038MB/B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that a patient being monitored in pulmonology underwent removal of a resolve pigtail 8.5fr pleural drain.This system requires a specific unlocking device, not available in service and likely included in the original box used during radiology placement.In accordance with the alternatives mentioned in the product's user manual, a section of the drain upstream of the locking system was created after clamping with forceps.The drain was removed without difficulty.However, the internal holding wire (the locking system wire) remained in the patient's chest.An attempt to manually remove this wire was initiated but had to be interrupted due to pain experienced by the patient.Removal was therefore postponed, a dressing was applied, and a reassessment was scheduled for the following day.At this reassessment, the thread was no longer present under the dressing, suggesting undocumented spontaneous or accidental removal.The patient was informed.
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 established.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.

• Brand Name: RESOLVE MINI LOCKING DRAINAGE CATHETER
• Common Device Name: LOCKING DRAINAGE CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana in?s de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• 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: 22796974
• Report Number: 1721504-2025-00244
• Device Sequence Number: 12840779
• Product Code: GBX
• UDI-Device Identifier: 00884450720158
• UDI-Public: 00884450720158
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: RML17-8-038MB/B
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/20/2025
• 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