MAUDE Adverse Event Report: COVIDIEN MICRO CATHETER

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)

Event Date 02/14/2017

Event Type  malfunction  

Event Description

Patient was undergoing an embolization procedure of a right frontal meningioma tumor.Specifically it included a 6 vessel diagnostic cerebral angiogram and permanent liquid embolization of the right frontal tumor.During the procedure, one of the microcatheters broke inside of the patient's blood vessel.The team attempted to retrieve it, but was unable to.The decision was made to push the catheter back to the right maxillary artery where it was embolized to secure it in that position.This event did not result in patient injury nor did it prolong the patient's hospitalization.Diagnosis or reason for use: right frontal tumor embolization.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: MICRO CATHETER
• Type of Device: MICRO CATHETER
• Manufacturer (Section D): COVIDIEN; minneapolis MN 55432
• MDR Report Key: 6348759
• MDR Text Key: 68109062
• Report Number: MW5067991
• Device Sequence Number: 1
• Product Code: KRA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 91