MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERWARE ADVANCE CORONARY GUIDEWIRE AND TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number DIAMONDBACK 360

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/29/2022

Event Type  Injury  

Event Description

Pt was having a coronary angiogram pt had a tight blockage of the circumflex artery.Md was using an atherectomy device, called csi to help open up the lesion.During the atherectomy procedure, a piece of the wire broke off into the coronary artery.Md placed a stent into the coronary artery, securing the wire against the vessel wall.The csi rep was contacted and came in during the case.The csi rep was given the lot number for the wire for tracking purposes.Pt remained stable throughout the entire procedure.Fda safety report id# (b)(4).

• Brand Name: VIPERWARE ADVANCE CORONARY GUIDEWIRE AND TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; st. paul MN 55112
• MDR Report Key: 15192704
• MDR Text Key: 297609786
• Report Number: MW5111346
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852580051831
• UDI-Public: 01108525800518317230331106235948
• 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: 08/04/2022

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: DIAMONDBACK 360
• Device Catalogue Number: GWC-12325LG-FLP
• Device Lot Number: 6235948
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORONARY STENT
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White