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

Catalog Number DC21452823/B

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device return at a later date, the investigation will be reopened.A good faith effort of 3 or more attempts to collect additional information regarding this event has been successfully completed in a timely manner.No additional information about this event has been provided.

Event Description

The account alleges that a dialysis catheter was successfully implanted on (b)(6) 2023.During the patient's dialysis procedure, the medical staff noted that the dialysis catheters hub was cracked and leaking blood.

Manufacturer Narrative

The suspect device was not 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 was found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PROGUIDE DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 16383295
• MDR Text Key: 309650497
• Report Number: 1721504-2023-00020
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884450697221
• UDI-Public: 884450697221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: DC21452823/B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DIALYSIS MACHINE CONNECTIONS