ATRIEVE VASCULAR SNARE 382006020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for ATRIEVE VASCULAR SNARE 382006020 manufactured by Argon Medical Devices Inc..

Event Text Entries

[115361265] The investigation is still ongoing. A follow-up report will be submitted with the completed evaluation.
Patient Sequence No: 1, Text Type: N, H10

[115361266] The loops broken in the blood tubes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1625425-2018-00085
• MDR Report Key: 7720465
• Date Received: 2018-07-25
• Date of Report: 2018-09-27
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2005-01-14
• Date Added to Maude: 2018-07-25
• 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. GAIL SMITH
• Manufacturer Street: 1445 FLAT CREEK ROAD
• Manufacturer City: ATHENS TX 75751
• Manufacturer Country: US
• Manufacturer Postal: 75751
• Manufacturer Phone: 2144368995
• Manufacturer G1: ARGON MEDICAL DEVICES INC.
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ATRIEVE VASCULAR SNARE
• Generic Name: VASCULAR SNARE
• Product Code: MMX
• Date Received: 2018-07-25
• Returned To Mfg: 2018-07-16
• Catalog Number: 382006020
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ARGON MEDICAL DEVICES INC.
• Manufacturer Address: 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-07-25