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

Model Number 00884450697221

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

The account alleges after implantation of a proguide dialysis catheter, the catheter was found to be cracked and leaked blood when trying to access the device.No additional patient consequence to report.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow-up report will be submitted once the investigation is complete.

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 ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16386488
• MDR Text Key: 309667485
• Report Number: 1721504-2023-00021
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884450697221
• UDI-Public: 00884450697221
• 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

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 Model Number: 00884450697221
• 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: 02/16/2023
• 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