APOLLO CATHETER 3.0CM 105-5096-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-13 for APOLLO CATHETER 3.0CM 105-5096-000 manufactured by Micro Therapeutics, Inc. Dba Ev3.

MAUDE Entry Details

• Report Number: 2029214-2019-00834
• MDR Report Key: 8888706
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-08-13
• Date of Report: 2019-10-25
• Date of Event: 2019-08-02
• Date Mfgr Received: 2019-10-10
• Device Manufacturer Date: 2019-04-25
• Date Added to Maude: 2019-08-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KATCHA TAYLOR
• Manufacturer Street: 9775 TOLEDO WAY
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 7635263305
• Manufacturer G1: MICRO THERAPEUTICS, INC. DBA EV3
• Manufacturer Street: 9775 TOLEDO WAY
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal Code: 92618
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: APOLLO CATHETER 3.0CM
• Generic Name: AGENT, INJECTABLE, EMBOLIC
• Product Code: MFE
• Date Received: 2019-08-13
• Returned To Mfg: 2019-09-03
• Model Number: 105-5096-000
• Catalog Number: 105-5096-000
• Lot Number: A821205
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3
• Manufacturer Address: 9775 TOLEDO WAY IRVINE CA 92618 US 92618

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-08-13