MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO .IMPRESS®.NON-BRAIDED.CATHETER; .PERIPHERAL CATHETERS

Catalog Number	465356SHP-NB/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during an ao run-off procedure in radiology department, the catheter tip detached within the patient.The physician had acquired retrograde right femoral artery access and had negotiated the patient's ilio-femoral conduit placing a stiff supra core.035 guide wire and the 4f pigtail catheter just inferior to the renal arteries within the ao for imaging and masking of the bilateral arterial conduit of the patient's lower periphery.While attempting to remove the catheter over the guidewire, a quick tug was executed by the physician.This is when the tip detached but remained on the guidewire within a calcified and diseased common iliac artery.The foreign body was pulled back to the primary access site along with the access guidewire.Due to the possible ifb migration, a secondary access point from the left femoral artery was successfully acquired.The physician used a vascular snare device to successfully externalize the foreign body from the patient's secondary access site, liberating the vessel.The patient tolerated the procedure well with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed, and the root cause is attributed to a weak fuse joint related to the manufacturing process.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: .PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18607560
• Report Number: 3011642792-2024-00009
• Device Sequence Number: 11474396
• Product Code: DQO
• UDI-Device Identifier: 00884450687567
• UDI-Public: 884450687567
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 07/07/2026
• Device Catalogue Number: 465356SHP-NB/A
• Device Lot Number: I2703470
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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