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

Catalog Number	7602-20M/B
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Reduced Blood Flow (4598)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
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 an endovascular repair case it was found that the catheter straightener went through the hub of the sheath and was deployed in the patient.This had to be surgically removed.This issue was identified when the patient presented with claudication a few days after the procedure.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint cannot be confirmed and a 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 no similar complaints for this lot were identified.

• 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: 22910003
• Report Number: 1721504-2025-00105
• Device Sequence Number: 8863142
• Product Code: DQO
• UDI-Device Identifier: 00884450001431
• UDI-Public: 00884450001431
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 09/10/2025

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
• Device Catalogue Number: 7602-20M/B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown