MAUDE Adverse Event Report: CSI- CARDIOVASCULAR SYSTEMS, INCORPORATED CSI VIPEWIRE DIAMONDBACK; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number REF # GWC-12325 LG- FP

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

Csi vipewire inserted via groin sheath for atherectomy by dr.(b)(6) while the device was in operation th tip of the wire broke off into th patients tp trunk.Using a snare, al missing portions of the wire were retrieved and the patient sustained no injury.Fda safety report id # (b)(4).

• Brand Name: CSI VIPEWIRE DIAMONDBACK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CSI- CARDIOVASCULAR SYSTEMS, INCORPORATED; st. paul MN 55112
• MDR Report Key: 9249819
• MDR Text Key: 164493727
• Report Number: MW5090736
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/25/2019

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: REF # GWC-12325 LG- FP
• Device Lot Number: 11100502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2019
• 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 Age: 45 YR
• Patient Weight: 83