MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - MEXICO .IMPRESS®.BRAIDED.4F.100 CM.BERENSTEIN..0 SIDE PORTS.0.038"; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	410038BER/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has returned for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The physician alleges that they crossed over the aortic bifurcation right to left, with a 4fr pigtail catheter and a competitors stiff guidewire.As they were pulling back on the catheter, the tip detached but remained on the guidewire.The physician removed the catheter and the guidewire together as a unit.No medical intervention necessary.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.Root cause is attributed to the manufacturing process.A review of the complaint database was performed and no similar complaints for this lot were identified.A review of the device history record was performed and no exception documents were found.

• Brand Name: .IMPRESS®.BRAIDED.4F.100 CM.BERENSTEIN..0 SIDE PORTS.0.038"
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21704290
• Report Number: 3011642792-2025-00026
• Device Sequence Number: 15985328
• Product Code: DQO
• UDI-Device Identifier: 00884450668795
• UDI-Public: 884450668795
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 410038BER/B
• Device Lot Number: I3028274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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