DRAGONFLY? OPTIS? CATHETER C408641

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 2019-09-09 for DRAGONFLY? OPTIS? CATHETER C408641 manufactured by St. Jude Medical Catd.

MAUDE Entry Details

• Report Number: 3009600098-2019-00021
• MDR Report Key: 8977442
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-09-09
• Date of Report: 2019-09-27
• Date of Event: 2019-09-02
• Date Mfgr Received: 2019-09-26
• Device Manufacturer Date: 2019-06-10
• Date Added to Maude: 2019-09-09
• 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: STEPHANIE O' SULLIVAN
• Manufacturer Street: 5050 NATHAN LANE NORTH
• Manufacturer City: PLYMOUTH MN 55442
• Manufacturer Country: US
• Manufacturer Postal: 55442
• Manufacturer Phone: 6517565400
• Manufacturer G1: ST. JUDE MEDICAL CATD
• Manufacturer Street: 4 ROBBINS DRIVE
• Manufacturer City: WESTFORD MA 01886
• Manufacturer Country: US
• Manufacturer Postal Code: 01886
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRAGONFLY? OPTIS? CATHETER
• Generic Name: DFII KITBOX OUS (NO SYRINGE)
• Product Code: ORD
• Date Received: 2019-09-09
• Returned To Mfg: 2019-09-19
• Model Number: C408641
• Lot Number: 7017146
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL CATD
• Manufacturer Address: 4 ROBBINS DRIVE WESTFORD MA 01886 US 01886

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-09