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

Catalog Number	46535BER/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
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 two catheter tips detached within the patient's common iliac arteries during catheter exchanges.The procedure was an infrarenal aortic aneurysm repair with noted tortuous left common iliac artery and calcified right cfa bilateral access site.The right access wire was exchanged [otw] for a stiff guidewire during the procedure and when the catheter was withdrawn, the catheter tip became stuck and detached.The left guidewire was also exchanged [otw] for a stiff hydrophilic wire during the procedure and when the second catheter was withdrawn, the catheter tip became stuck and detached as well.Both foreign bodies were successfully snared and removed from the patient with no additional consequences to report.
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®.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: 18178463
• Report Number: 3011642792-2023-00074
• Device Sequence Number: 7568147
• Product Code: DQO
• UDI-Device Identifier: 00884450024928
• UDI-Public: 884450024928
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/14/2023

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: 08/04/2026
• Device Catalogue Number: 46535BER/B
• Device Lot Number: I2739005
• 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: 11/14/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STIFF HYDROPHILIC .035; STIFF LUNDERQUIST GUIDEWRIE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown