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

Catalog Number	56535RIM
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body Embolism (4439); Thrombosis/Thrombus (4440)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during a peripheral vascular angiogram of a patient's right leg, the catheter tip detached.The clinician had acquired left retrograde femoral artery access and had negotiated the patient's steep ilio-femoral conduit with a guidewire and the 5f catheter.During an over-the-wire catheter exchange within the patient's calcified iliac bifurcation, the catheter tip detached.The physician used a vascular snare device to successfully externalized the foreign body via bilateral femoral artery access thus liberating the vessel.The foreign body retrieval was complicated by a thrombogenic reaction caused by the detached foreign body with thrombosis noted within the common iliac, external iliac, and the profunda arteries.The patient was put on heparin infusion overnight, however due to the continued ischemic complications, the adverse event resulted in a below knee amputation.
Additional Manufacturer Narrative
The suspect device is expected to return for investigation.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed, and the root cause is attributed to elongation as he device passed through torturous anatomy.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 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: 15510357
• Report Number: 3010665433-2022-00097
• Device Sequence Number: 5242525
• Product Code: DQO
• UDI-Device Identifier: 00884450038185
• UDI-Public: 884450038185
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/14/2022

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: 02/10/2025
• Device Catalogue Number: 56535RIM
• Device Lot Number: E2354764
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2023
• 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 GUIDEWIRE; STIFF HYDROPHILIC GUIDEWIRE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Sex: Unknown