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

Lot Number 11191658

Device Problems Break (1069); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

While performing orbital atherectomy in lad, tip of wire broke off and traveled into the small septal branch where it remains.Fda safety report id# (b)(4).

• Brand Name: VIPERWIRE ADVANCE CORONARY GUIDE WIRE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. ; 1225 old highway 8nw; MO 55112
• MDR Report Key: 11278683
• MDR Text Key: 230472493
• Report Number: MW5099208
• Device Sequence Number: 1
• Product Code: MCW
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Lot Number: 11191658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 107