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

Model Number	00884450023426
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a dialysis procedure on a 45yo male patient, a long-term hemodialysis catheter in the patient's right neck was fixed in place.The catheter end was used to withdraw fluid smoothly for preparation of dialysis.There was a noted crack in the threads opening at the arterial end, about 1cm.The withdrawal of fluid was smooth and accompanied by continuous air bubbles.This was immediately reported to the physician on duty.The physician wanted to seal the patient's tube for continued use and eventually replace the catheter when possible.No injury of the patient to report.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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 similar complaints were identified.

• Brand Name: PROGUIDE¿
• Common Device Name: 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 ; 8012084662
• MDR Report Key: 16985924
• Report Number: 1721504-2023-00051
• Device Sequence Number: 6771744
• Product Code: MSD
• UDI-Device Identifier: 00884450023426
• UDI-Public: 00884450023426
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: 05/30/2025
• Device Model Number: 00884450023426
• Device Catalogue Number: DC21452419/CNA
• Device Lot Number: H2466569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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 Age: 45 YR
• Patient Sex: Male