MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE CORONARY GUIDE WIRE; CATHETER, CORONARY, ATHERECTOMY

Model Number GWC-12325LG-FT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2019

Event Type  Injury  

Event Description

Post orbital atherectomy, wire was removed and viper wire tip broke off.Md was unable to remove.Pt required emergency surgery to remove the piece of wire.Emergency coronary artery bypass graft surgery x 1 with saphenous vein graft anastomosed to the obtuse marginal branch of the left circumflex coronary artery; removal of intracoronary foreign body; endoscopic left greater saphenous vein harvest; epicardial ventricular pacing wire placement.Fda safety report id# (b)(4).

• Brand Name: VIPERWIRE ADVANCE CORONARY GUIDE WIRE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. ; st. paul MN 55112
• MDR Report Key: 9569599
• MDR Text Key: 174666234
• Report Number: MW5092125
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 257540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 69