MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT MEDICAL 5FR X 100CM VERTEBRAL CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 5583-13

Device Problem Break (1069)

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

Event Date 10/03/2019

Event Type  malfunction  

Event Description

Catheter tip broke off during endovascular procedure.Tip retrieved during procedure with no adverse sequelae.

• Brand Name: MERIT MEDICAL 5FR X 100CM VERTEBRAL CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w. merit pkwy; south jordan UT 84095
• MDR Report Key: 11055445
• MDR Text Key: 223382031
• Report Number: MW5098473
• Device Sequence Number: 1
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/17/2020

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: 5583-13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 87