DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM DBEC-125 70058-13

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2020-03-30 for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM DBEC-125 70058-13 manufactured by Cardiovascular Systems, Inc..

MAUDE Entry Details

• Report Number: 3004742232-2020-00097
• MDR Report Key: 9898398
• Report Source: HEALTH PROFESSIONAL,STUDY,USE
• Date Received: 2020-03-30
• Date of Report: 2020-03-30
• Date of Event: 2020-03-13
• Date Mfgr Received: 2020-03-25
• Device Manufacturer Date: 2019-12-16
• Date Added to Maude: 2020-03-30
• 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: MRS. LARAMIE OTTO
• Manufacturer Street: 1225 OLD HIGHWAY 8 NW
• Manufacturer City: ST. PAUL, MN, MN
• Manufacturer Country: US
• Manufacturer Phone: 2591600
• Manufacturer G1: CARDIOVASCULAR SYSTEMS, INC.
• Manufacturer Street: 1225 OLD HIGHWAY 8 NW
• Manufacturer City: ST. PAUL, MN, MN
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Generic Name: CORONARY ATHERECTOMY DEVICE
• Product Code: MCX
• Date Received: 2020-03-30
• Model Number: DBEC-125
• Catalog Number: 70058-13
• Lot Number: 303549
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDIOVASCULAR SYSTEMS, INC.
• Manufacturer Address: 1225 OLD HIGHWAY 8 NW ST. PAUL, MN, MN US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2020-03-30