MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HIGH PRESSURE TUBING

Catalog Number	HPF720E/B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and the complaint is confirmed.Root cause is attributed to rough handling by the user.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot were identified.
Event or Problem Description
The account alleges that the thread on the tubing was broken and came off inside the cobra probe.The device was replaced and procedure was continued with no consequences to the patient.

• Brand Name: HIGH PRESSURE TUBING
• Common Device Name: HIGH PRESSURE TUBING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana in?s de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit pkwy; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 w merit pkwy; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22731604
• Report Number: 1721504-2025-00222
• Device Sequence Number: 15695245
• Product Code: FPK
• UDI-Device Identifier: 00884450568149
• UDI-Public: 00884450568149
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K883718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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 Catalogue Number: HPF720E/B
• Device Lot Number: I3094977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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