MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO IMPRESS BRAIDED CATHETER

Catalog Number 56538KA2/JPB

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/21/2024

Event Type  Injury  

Event Description

The account alleges that the black tip of an impress catheter detached and remained within blood vessel during use.The detached portion was successfully retrieved out of the patient.No other injury has been reported.

Manufacturer Narrative

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

Manufacturer Narrative

This report was submitted in error and is a duplicate of 3011642792-2024-00018.Report 3011642792-2024-00018 will be used for complete details and future updates of this event moving forward.

• Brand Name: IMPRESS BRAIDED CATHETER
• Type of Device: IMPRESS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, ca 92154 ; EI 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, ca 92154 ; EI 92154
• Manufacturer Contact: bryson heaton bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 18993060
• MDR Text Key: 338815492
• Report Number: 3011642792-2024-00019
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 56538KA2/JPB
• Device Lot Number: I2593040
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2024
• 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
• Patient Outcome(s): Required Intervention