MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEM INCORPORATED VIPERWIRE ADVANCED CORONARY GUIDE WIRE WITH FLEX TIP 325CM; CATHETER, CORONARY, ATHERECTOMY

Model Number GWC-12325LG-FT

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/17/2022

Event Type  Injury  

Event Description

During cardiac catheterization, a small fragment of the distal viper wire separated and got stuck in the apical lad.Multiple attempts were made to retrieve the fragment but was unsuccessful.

• Brand Name: VIPERWIRE ADVANCED CORONARY GUIDE WIRE WITH FLEX TIP 325CM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEM INCORPORATED; st. paul MN 55112
• MDR Report Key: 15371421
• MDR Text Key: 299471750
• Report Number: MW5111899
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 419795-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White