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

Model Number	C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Pigtail back end broke off while being used.No harm to the patient as that end was outside the patient.It was able to be removed without harm.

• Brand Name: PERFORMA®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 24616618
• Report Number: 24616618
• Device Sequence Number: 9575809
• Product Code: DQO
• UDI-Device Identifier: 00884450843017
• UDI-Public: (01)00884450843017
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/05/2026
• Report Date (Section F): 02/05/2026

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 Model Number: C
• Device Catalogue Number: 7742-20M65SH
• Device Lot Number: I3188674
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Date Report Sent to FDA: 02/05/2026