MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM; ORBIT II

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Nausea (1970); Vomiting (2144)

Event Date 10/19/2012

Event Type  Death  

Event Description

Device and doctor caused death.This device was used on my father by (b)(6), do.(b)(6) said he opened the artery.My father said he felt nauseous and vomited blood.(b)(6) continued procedure.He said the next thing he knew my father's heart stopped, he stopped breathing.They performed cpr and tried to open his airway.Taken to icu, lasted 51 days at (b)(6) hospital.On (b)(6) 2012, first part of angioplasty, standard method and instrument.My father had no issues or problems tolerating this procedure, so it is beyond my scope of understanding why (b)(6) used on experimental instrument on (b)(6) 2012 - 2 stents implanted.Second part of cardiac (angioplasty) procedure on (b)(6) 2012, didn't get a chance to put in stent after using this device, bleeding and heart stopped.

• Brand Name: DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
• Type of Device: ORBIT II
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC
• MDR Report Key: 4465737
• MDR Text Key: 5185640
• Report Number: MW5040423
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/03/2014

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?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR