MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING .IMPRESS®.NON-BRAIDED.CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	4653510STF-NB
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during an endovascular aortic repair [evar] procedure, the catheter tip detached within the patient.The physician had successfully navigated the ilio-femoral conduit and acquired bilateral femoral artery access.A guidewire was then advanced to the aneurysm site.During guidewire manipulations, the physician noted the catheter tip was missing and had migrated to the patient's aortic bifurcation.The foreign body was successfully externalized, liberating the vessel along with all residual interventional equipment.A competitor's device was used to complete the procedure for this patient.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The returned sample evaluation concluded that the most probable root cause of the occurrence was forces imposed upon the device during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: .IMPRESS®.NON-BRAIDED.CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16679188
• Report Number: 3010665433-2023-00032
• Device Sequence Number: 8116586
• Product Code: DQO
• UDI-Device Identifier: 00884450029541
• UDI-Public: 884450029541
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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: 03/28/2025
• Device Catalogue Number: 4653510STF-NB
• Device Lot Number: E2390050
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown