MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERWIRE ADVANCE CORONARY; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number 453054901-GWC-12325LG-FT

Patient Problems Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Respiratory Arrest (4461)

Event Date 08/04/2023

Event Type  Death  

Event Description

Patient undergoing arthrectomy, bp raised from baseline and patient went into full arrest.Physician discovered broken wire a couple minutes into resuscitation.Patient pronounced dead.

• Brand Name: VIPERWIRE ADVANCE CORONARY
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 17563958
• MDR Text Key: 321364854
• Report Number: MW5144627
• Device Sequence Number: 1
• Product Code: MCW
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 453054901-GWC-12325LG-FT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Race: White