VECTRA VASCULAR ACCESS GRAFT WITH GRADUATED REINFORCEMENT 10002-5040-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for VECTRA VASCULAR ACCESS GRAFT WITH GRADUATED REINFORCEMENT 10002-5040-001 manufactured by Thoratec Corporation.

MAUDE Entry Details

• Report Number: 2916596-2019-02929
• MDR Report Key: 8716787
• Date Received: 2019-06-20
• Date of Report: 2019-08-20
• Date of Event: 2017-05-19
• Date Mfgr Received: 2019-08-13
• Device Manufacturer Date: 2008-09-28
• Date Added to Maude: 2019-06-20
• 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: MR. BOB FRYC
• Manufacturer Street: 6035 STONERIDGE DRIVE
• Manufacturer City: PLEASANTON CA 94588
• Manufacturer Country: US
• Manufacturer Postal: 94588
• Manufacturer Phone: 7818528204
• Manufacturer G1: THORATEC CORPORATION
• Manufacturer Street: 6035 STONERIDGE DRIVE
• Manufacturer City: PLEASANTON CA 95488
• Manufacturer Country: US
• Manufacturer Postal Code: 95488
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: VECTRA VASCULAR ACCESS GRAFT WITH GRADUATED REINFORCEMENT
• Generic Name: 5.0MM X 40CM, WITH GRADUATED REINFORCEMENT
• Product Code: DYF
• Date Received: 2019-06-20
• Returned To Mfg: 2017-07-07
• Catalog Number: 10002-5040-001
• Lot Number: 706333
• Device Expiration Date: 2013-09-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THORATEC CORPORATION
• Manufacturer Address: 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-20