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

Model Number UNK-NV-ONYX

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been received for evaluation; therefore, the event cause could not be determined.Correspondence has been sent for the device and response was received stating that the device will be kept by facility and sent back 12 months later.Once the device has been received and investigation completed, a supplemental report will be submitted.Reference mdr# 2029214-2019-00546.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report through mw5086345 that medtronic microcatheter fractured during liquid embolization treatment.It was reported that while watching under direct fluoroscopic visualization to ensure no traction was put on the liquid embolic cast, and following vital signs with continuous monitoring.Additional pressure was gradually applied over 5 mins until the microcatheter released, noted a small *thread* of medtronic liquid embolic in the microcatheter as the level of the a1 segment which suggested fractured of the catheter.Direct visualization of the echelon on the table revealed that the distal portion of the catheter was no longer attached as evidence of the lack of the two distal markers.Complication of retained microcatheter tip in the onyx cast.It was noted that the echelon microcatheter tip was removed from the patient.

• 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 ; 7635263305
• MDR Report Key: 8694804
• MDR Text Key: 147852093
• Report Number: 2029214-2019-00547
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/13/2019

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: UNK-NV-ONYX
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/13/2019
• 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): Disability