MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number VPR-GW-EL14

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2022

Event Type  Injury  

Event Description

When guidewire was removed, not intact.Md aware, device representative aware.Cv surgeon consulted - np at bedside speaking with patient and physician.Patient and family notified.Device and packaging obtained for inspection and review.Patient access and monitored.Device visualized on fluoroscopy, md states in stable position, no treatment necessary at this time.Fda safety report id # (b)(4).

• Brand Name: VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; st. paul MN 55112
• MDR Report Key: 13995738
• MDR Text Key: 288622195
• Report Number: MW5108731
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 108525280054559
• UDI-Public: (01)108525280054559
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: VPR-GW-EL14
• Device Lot Number: 411232-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• 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 Sex: Male