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

Catalog Number 46538CB2-H

Device Problems Fracture (1260); Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  Injury  

Event Description

The account alleges that during a ufe procedure, the catheter tip fragmented within the patient.The physician had acquired radial access and had negotiated the patient's ilio-femoral conduit with a guidewire and the 4f catheter.During over-the-wire catheter manipulations within the patient's vasculature system the tip fragmented.The physician used a vascular snare device to successfully externalize the fragmented tip liberating the vessel.No additional patient consequences to report.

Manufacturer Narrative

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

• Brand Name: .IMPRESS®.BRAIDED CATHETER
• Type of Device: INTRAVASCULAR, DIAGNOSTIC PERIPHERAL CATHETER
• 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: 16946559
• MDR Text Key: 315387827
• Report Number: 3010665433-2023-00041
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450042557
• UDI-Public: 884450042557
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K093004
• 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
• Report Date: 05/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 46538CB2-H
• Device Lot Number: E2204734
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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: IMPRESS COBRA 1 CATHETER; IMPRESS SIM1 CATHETER; INTERVENTIONAL GUIDEWIRE
• Patient Outcome(s): Required Intervention