MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PERFORMA®; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	1623-F220M/JPB
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a stent graft procedure, when removing the sizing catheter while leaving the egoist ultimate in place, the hub and catheter connection detached.Since the shaft part was outside the body, the remaining catheter was removed.A new one from the same lot was opened and the procedure completed with it.No patient injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and the defect as reported by the customer has been observed.It appears that detached hub and stretched catheter occurred during use, as such the root cause cannot be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and one similar complaint for this lot was identified.

• Brand Name: PERFORMA®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA ; MX
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22939740
• Report Number: 1721504-2025-00325
• Device Sequence Number: 9879200
• Product Code: DQO
• UDI-Device Identifier: 00884450230039
• UDI-Public: 00884450230039
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K000659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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
• Device Catalogue Number: 1623-F220M/JPB
• Device Lot Number: I3152308
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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