MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO IMPRESS® BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 46538BER/B

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

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

Event Date 03/28/2024

Event Type  Injury  

Event Description

The account alleges that while removing the device during the procedure, the catether detached within the patient.The clinician was able to successfully remove the detached piece without futher intervention.No additional patient consequence to report.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed, and the root cause is attributed to a weak fuse joint related to the manufacturing process.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: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 19075977
• MDR Text Key: 339990884
• Report Number: 3011642792-2024-00021
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450668931
• UDI-Public: 884450668931
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46538BER/B
• Device Lot Number: I2862014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 06/05/2024
• Supplement Dates FDA Received: 06/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2024
• 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