PROPLEGE CORONARY SINUS CATHETER MODEL PR9

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 2020-01-02 for PROPLEGE CORONARY SINUS CATHETER MODEL PR9 manufactured by Edwards Lifesciences.

MAUDE Entry Details

• Report Number: 3008500478-2020-00182
• MDR Report Key: 9539338
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-01-02
• Date of Report: 2019-12-09
• Date of Event: 2019-12-06
• Date Mfgr Received: 2019-12-09
• Date Added to Maude: 2020-01-02
• 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: MS. AMRITHA SRINIVASAN
• Manufacturer Street: ONE EDWARDS WAY
• Manufacturer City: IRVINE CA 92614
• Manufacturer Country: US
• Manufacturer Postal: 92614
• Manufacturer Phone: 9492504062
• Manufacturer G1: EDWARDS LIFESCIENCES LLC
• Manufacturer Street: ONE EDWARDS WAY
• Manufacturer City: IRVINE CA 92614
• Manufacturer Country: US
• Manufacturer Postal Code: 92614
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROPLEGE CORONARY SINUS CATHETER MODEL PR9
• Generic Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Product Code: DWF
• Date Received: 2020-01-02
• Returned To Mfg: 2020-01-10
• Model Number: PR9
• Catalog Number: PR9
• Lot Number: 62487643
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EDWARDS LIFESCIENCES
• Manufacturer Address: ONE EDWARDS WAY IRVINE CA 92614 US 92614

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-01-02