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

Model Number	00884450043769
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that at the beginning of the procedure, the doctor requested a puncture needle and 5f introducer, later he requested a hydrophilic guidewire and a 5f catheter.As it was a fibroid embolization, the doctor suggested using a uac catheter, but he rejected it.After introducing the 5f catheter into the patient, during its manipulation by the doctor, the hydrophilic tip dislodged, the doctor removed it with an endovascular loop, the doctor managed to remove the fragments lodged inside the patient and the intervention ended.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device tip and fractured pieces were both evaluated under 20x magnification and confirmed to be sharp fractures.The fuse joint of the tip to the catheter was determined to be present and adequate.Root cause could not be determined.A review of the device history record was performed and no similar complaints for this lot were identified.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC. -; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 16675233
• Report Number: 3011642792-2023-00029
• Device Sequence Number: 17463423
• Product Code: DQO
• UDI-Device Identifier: 00884450043769
• UDI-Public: 00884450043769
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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 Expiration Date: 01/12/2024
• Device Model Number: 00884450043769
• Device Catalogue Number: 56538CB1-H
• Device Lot Number: E2039200
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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