MAUDE Adverse Event Report: COVIDIEN ONYX AVM; LIQUID EMBOLIC

Model Number 105-7000-065

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Material Separation (1562)

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

Event Date 10/21/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient underwent onyx embolization treatment.The patient¿s anatomy was normal in tortuosity.During the procedure and on the second injection of the second bottle of onyx, the catheter got loosened shortly and separated approximately 4cm behind the hub.Onyx was seen to be leaking onto the operating table.All the pieces were removed from the patient and no onyx was seen in any unintended vessel.No patient injury was reported as a result of the procedure.Same event as mdr# 2029214-2014-00663.

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was consumed in the event.(b)(4).

• Brand Name: ONYX AVM
• Type of Device: LIQUID EMBOLIC
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN(IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4265174
• MDR Text Key: 5297229
• Report Number: 2029214-2014-00664
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2014

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: 03/04/2017
• Device Model Number: 105-7000-065
• Device Lot Number: 9952913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2014
• 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