MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. VIPERWIRE; VIPERWIRE CORONARY WIRE

Model Number GWC-12325LG-FLP

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2016

Event Type  Injury  

Event Description

Use of orbital atherectomy device csi and wire was cut-off and remains in coronary artery of pt.Pt went for emergent open heart surgery.

• Brand Name: VIPERWIRE
• Type of Device: VIPERWIRE CORONARY WIRE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; st. paul MN
• MDR Report Key: 5620366
• MDR Text Key: 44140506
• Report Number: MW5061980
• Device Sequence Number: 1
• Product Code: MCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: GWC-12325LG-FLP
• Device Lot Number: 10507226
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 82