MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PROGUIDE CHRONIC DIALYSIS CATHETER

Catalog Number	DC01452419
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.
Event or Problem Description
The account alleges during the procedure for implantation of a permanent catheter in the right internal jugular vein, the patient experienced a complication related to the medical device.As a result, the procedure was suspended and the catheter was removed.Due to the complexity of the vascular access, the patient was urgently referred to interventional radiology.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation, two videos depicting a leaking catheter were provided.This leak is occurring very close to the location that the catheter may be sutured in place.It is unknown if the catheter was punctured during use or if it arrived damaged.The root cause cannot be determined.A search of the complaint database was performed and no similar complaint for this lot number was found.The device history record was reviewed, and no exception documents were found.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: PROGUIDE CHRONIC DIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• 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: 22647402
• Report Number: 1721504-2025-00203
• Device Sequence Number: 8632501
• Product Code: MSD
• UDI-Device Identifier: 00884450029732
• UDI-Public: 00884450029732
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: DC01452419
• Device Lot Number: H3174793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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