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

Catalog Number	DC01453631/A
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that the hemodialysis catheter was not providing good flow.The next day the catheter was changed for a new one in the right jugular and it is currently reported to be functioning correctly.
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 was performed and no exception documents were identified.A review of the complaint database was performed and two similar complaints for this lot number were found from the same account.

• Brand Name: PROGUIDE CHRONIC DIALYSIS CATHETER
• Common Device Name: CHRONIC 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: 19981727
• Report Number: 1721504-2024-00053
• Device Sequence Number: 15547272
• Product Code: MSD
• UDI-Device Identifier: 00884450096413
• UDI-Public: 00884450096413
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: DC01453631/A
• Device Lot Number: H2845482
• 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: 08/02/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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
• Patient Sex: Unknown