MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. RESOLVE® LOCKING DRAINAGE.CATHETER.10F.PIGTAIL.MARKER BAND.0.038" (0.97 MM); CATHETER, IRRIGATION

Model Number	00884450580615
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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
Customer reports while exchanging a multipurpose drain that had a crack in the catheter, the catheter fell apart at the radiopaque marker leaving part of the catheter in the patient.They were able to eventually get the rest of the catheter out but on inspection it appears it was also coming apart on the distal side of the marker as well.No additional patient details were provided and no injury was reported.
Additional Manufacturer Narrative
The suspect device was 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 corrective actions are taken as warranted.Trend data will be used to monitor complaints and the performance of production processes and quickly address any deviations from established standards.

• Brand Name: RESOLVE® LOCKING DRAINAGE.CATHETER.10F.PIGTAIL.MARKER BAND.0.038" (0.97 MM)
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana inés 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: 22787641
• Report Number: 1721504-2025-00240
• Device Sequence Number: 8286494
• Product Code: GXB
• UDI-Device Identifier: 00884450580615
• UDI-Public: 00884450580615
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: 00884450580615
• Device Catalogue Number: RLC-10-038MB/C
• Device Lot Number: I3076036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown