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

Catalog Number 56535RIM

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Foreign Body Embolism (4439); Thrombosis/Thrombus (4440)

Event Date 09/14/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

The suspect device is expected to return for investigation.A follow-up report will be submitted once the investigation is complete.

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
• Type of Device: 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
• MDR Text Key: 300887946
• Report Number: 3010665433-2022-00097
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450038185
• UDI-Public: 884450038185
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 56535RIM
• Device Lot Number: E2354764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STIFF GUIDEWIRE; STIFF HYDROPHILIC GUIDEWIRE
• Patient Outcome(s): Hospitalization; Required Intervention; Disability