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

Catalog Number	46538CB2-H
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3010665433-2023-00041
• Device Sequence Number: 2381633
• Product Code: DQO
• UDI-Device Identifier: 00884450042557
• UDI-Public: 884450042557
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K093004
• 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
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 46538CB2-H
• Device Lot Number: E2204734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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: IMPRESS COBRA 1 CATHETER; IMPRESS SIM1 CATHETER; INTERVENTIONAL GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown