MAUDE Adverse Event Report: MEDTRONIC COVIDIEN ONYX KIT; AGENT, INJECTABLE, EMBOLIC

Model Number 105-8300-500

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

The onyx was not returned for evaluation as it was consumed in the event.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.Note: per the onyx ifu (instructions for use): difficult catheter removal or catheter entrapment may be caused by one or more of the following factors: long catheterization time, angioarchitecture, vasospasm, reflux and/or injection time.Information received from the same article as mfr: 2029214-2015-05032.

Event Description

The following report was received by medtronic (covidien): during onyx embolization of an arteriovenous malformation (avm) located near the occipital artery the marathon catheter became entrapped.Upon attempting to remove the marathon catheter the distal segment of catheter broke off and remains within the patient in the occipital artery.The vessel was moderate in tortuosity.The patient is noted to be doing fine with no effects of the catheter being left behind.There were no symptoms or complications associated with this event.The catheter was flushed and prepared as per the ifu.The catheter will not be returned as it was discarded by the customer.

Event Description

The microcatheter was left in the occipital artery, approximately 100 cm long.There was report of vasospasm which was treated with verapamil.The duration of the onyx injection was 25 min with no more than 1.5 min pause for reflux.The patient is noted to be doing fine with no effects of the catheter being left behind.

• Brand Name: ONYX KIT
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5131551
• MDR Text Key: 27778103
• Report Number: 2029214-2015-05033
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H060003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-8300-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• 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): Other