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

Catalog Number	7757-2MP80SH/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during device use, as the catheter approached the aorta, the distal end of the catetheter broke and detached.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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.
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.

• Brand Name: PERFORMA NON-BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22913069
• Report Number: 1721504-2025-00298
• Device Sequence Number: 9221340
• Product Code: DQO
• UDI-Device Identifier: 00884450770658
• UDI-Public: 00884450770658
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K943739
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 08/28/2025
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown