MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CENTROSFLO®; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	CENFT23K
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The customer alleges that the valve of the peel-away sheath was attached in an irregular shape.Although the physician using the device felt discomfort with it, he used the product, which resulted in severe bleeding from the patient.The patient was given a blood transfusion after the procedure.The catheter itself was implanted, and the patient started dialysis without any problems from the following day of the occurrence date.The patient had severe valvular disease as an underlying condition, which may have caused the severe bleeding, but the causal relationship between the patient's bleeding and his/her underlying condition is unknown.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The most probable cause of this occurrence is failure of the component.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: CENTROSFLO®
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 21209499
• Report Number: 1721504-2025-00014
• Device Sequence Number: 18160306
• Product Code: MSD
• UDI-Device Identifier: 00884450276129
• UDI-Public: 00884450276129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 01/14/2026
• Device Catalogue Number: CENFT23K
• Device Lot Number: H2642803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown