MAUDE Adverse Event Report: CSI CARDIOVASCULAR SYSTEMS INCORPORATED VIPER WIRE CSI; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number VPR-GW-14

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

A peripheral csi wire was used in a coronary case.The wire fractured.The wires are 2 different sizes.Fda safety report id # (b)(4).

• Brand Name: VIPER WIRE CSI
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CSI CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 11307040
• MDR Text Key: 231587576
• Report Number: MW5099302
• Device Sequence Number: 1
• Product Code: MCW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization