MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number UNKNOWN

Device Problem Entrapment of Device (1212)

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

Event Type  malfunction  

Manufacturer Narrative

The onyx was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.Upon receipt of the additional information a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that catheter entrapment in an onyx cast.There was not any further information received at this time.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10084875
• MDR Text Key: 199528731
• Report Number: 2029214-2020-00484
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2020

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 Model Number: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 05/24/2020
• Was Device Evaluated by Manufacturer?: No
• 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