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

Catalog Number	DC21452823/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot number were found.
Event or Problem Description
The customer alleges that the catheter detached within the patient post-procedure.A chest x-ray was performed confirming catheter detachment at the level of the left edge of the cardiac silhouette, hospitalizing the patient for two days until his health improved.The patient was taken for foreign body removal and insertion of a new dialysis catheter on (b)(6) 2024.On (b)(6) 2024 he was discharged with favorable evolution.

• Brand Name: PROGUIDE CHRONIC DIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 20015451
• Report Number: 1721504-2024-00056
• Device Sequence Number: 18290438
• Product Code: MSD
• UDI-Device Identifier: 00884450012536
• UDI-Public: 00884450012536
• 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
• Report Date (Section B): 08/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: DC21452823/A
• Device Lot Number: H2821270
• 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: 08/05/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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; Life Threatening
• Patient Sex: Unknown