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

Model Number GWC-12325LG-FT

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/23/2023

Event Type  Injury  

Event Description

While the cardiologist was performing an atherectomy on the lad, the end of the wire broke off and remained in the distal lad; the wire was retrieved with a snare device.

• Brand Name: VIPER WIRE ADVANCE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.
• MDR Report Key: 17011064
• MDR Text Key: 316103286
• Report Number: MW5117915
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 380174-1
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White