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

Catalog Number	7757-2MP80SH/B
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	08/12/2025
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 procedure they opened a catheter and tested it on the table.The tip of the catheter detached at the junction between the blue and white portion of the catheter.
Additional Manufacturer Narrative
The suspect device has not returned for evaluation.The complaint cannot be confirmed and a root cause cannot be determined at this time.If the device returns at a later date, the complaint will be reopened and a complete investigation will be performed.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 number were identified.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The catheter was found to be fractured; however, the root cause of the failure could not 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 no similar complaints for this lot number were identified.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: PERFORMA®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• 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: 22909969
• Report Number: 1721504-2025-00309
• Device Sequence Number: 13044115
• Product Code: DQO
• UDI-Device Identifier: 00884450770658
• UDI-Public: 00884450770658
• Combination Product (Y/N): Y
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 10/22/2025

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: 7757-2MP80SH/B
• Device Lot Number: I3164239
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 10/22/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown