MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE DVANCE CORONARY , 0.012" DIA SPRING TIP, 325CM

Model Number 72010-01

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 12/03/2018

Event Type  Death  

Event Description

During high risk pci, tip of csi/vipe wire broke off into the circumflex coronary artery.

• Brand Name: VIPERWIRE
• Type of Device: DVANCE CORONARY , 0.012" DIA SPRING TIP, 325CM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. ; 1225 old hwy 8 nw; saint paul MN 55112
• MDR Report Key: 8214457
• MDR Text Key: 132071771
• Report Number: 8214457
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 72010-01
• Device Lot Number: 10951444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2018
• Distributor Facility Aware Date: 12/03/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 12/28/2018 Patient Sequence Number: 1