MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE CORONARY GUIDEWIRE; CATHETER, CORONARY, ATHERECTOMY

Model Number GWC-12325LGF-FT

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/14/2020

Event Type  Injury  

Event Description

Tip of viperwire broke off inside rcp unable to retrieve.Fda safety report id#: (b)(4).

• Brand Name: VIPERWIRE ADVANCE CORONARY GUIDEWIRE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. ; st paul MN 55112
• MDR Report Key: 10307403
• MDR Text Key: 199989435
• Report Number: MW5095641
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: GWC-12325LGF-FT
• Device Lot Number: 311379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• 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: 80 YR