MAUDE Adverse Event Report: COVIDIEN (IRVINE) ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

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

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device will not been returned for analysis as it was implanted; therefore the complaint could not be determined.However as reported, 10mm (1cm) catheter was entrapped by onyx.Per onyx les instruction for use: "do not allow more than 1cm of onyx les reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx reflux or prolonged injection time may result in difficult catheter removal and catheter entrapment.Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.The long term effects of an entrapped catheter that is left in a patient is unknown, but could potentially include clot formation, infection, or catheter migration.".

Event Description

Medtronic received information that after use of the onyx the marathon microcatheter tip became entrapped by onyx and could not be removed.After attempts to remove the catheter, the tip detached 20cm from the distal tip.During procedure to treat the cerebral arteriovenous fistula, the physician used 2 vials of onyx 18 and tried to remove the marathon microcatheter after injection.However, the catheter tip was trapped by onyx, and the catheter was hard to remove.Approximately 10mm of the distal end of the microcatheter was trapped with the onyx.The physician applied tension then loosened repeatedly for 6 minutes.Then the catheter tip got torn and separated at 20 cm from the tip.The physician tried to capture the torn piece with a snare but failed to do so, and the piece was left inside the patient.The procedure was completed without further intervention and no injury to the patient has been reported.

Manufacturer Narrative

Please reference mdrs 2029214-2016-00898 and 2029214-2016-00899 for the other devices referenced in this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6027992
• MDR Text Key: 57424521
• Report Number: 2029214-2016-00898
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2016

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: 02/04/2019
• Device Model Number: 105-7100-060
• Device Lot Number: A245033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided; 09/15/2016
• Supplement Dates FDA Received: 10/13/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2016
• 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