MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS BRAIDED VERTEBRAL CATHETER

Catalog Number 510038VER-H

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2023

Event Type  malfunction  

Event Description

During an ir procedure, the catheter tip detached within a patient.No additional interventions were deemed necessary to prevent permanent impairment of body function or structure.A new device was used to complete this procedure.No additional patient consequences to report.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect medical device was returned for an evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: IMPRESS BRAIDED VERTEBRAL CATHETER
• Type of Device: VERTEBRAL 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: 17781970
• MDR Text Key: 323847877
• Report Number: 3010665433-2023-00078
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K093004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

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 Expiration Date: 04/13/2024
• Device Catalogue Number: 510038VER-H
• Device Lot Number: E2102620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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