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

Catalog Number	DC01453631/A
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that a femoral hemodialysis catheter was implanted in the patient.The account alleges that the catheter is not allowing good flow pressures during the dialysis procedure extending dialysis time for the patient.A new ij catheter was placed and the patient experienced the same low flow values again.The patient returned to the hospital for another hemodialysis catheter the next day.The hd catheter was exchanged and was found to be operating correctly.
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: CHRONIC DIALYSIS CATHETER PROGUIDE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19997522
• Report Number: 1721504-2024-00055
• Device Sequence Number: 12577260
• Product Code: MSD
• UDI-Device Identifier: 00884450096413
• UDI-Public: 884450096413
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 08/15/2024
• 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