MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC DIAMONDBACK 360; CATHETER, CORONARY, ATHERECTOMY

Model Number DBEC-125

Device Problems Protective Measures Problem (3015); Noise, Audible (3273)

Patient Problems Calcium Deposits/Calcification (1758); Chest Pain (1776)

Event Date 09/26/2018

Event Type  malfunction  

Event Description

The patient was admitted for chest pain and was taken to the cardiac cath suite; noted to have left anterior disease (lad) severe calcification.During the procedure,the device diamondback 360 stopped working appropriately.During use, staff and physician reported the device was making a "grunting noise".The physician immediately stopped and removed the device, guide wire, and guide catheter as a single unit.All pieces came out intact.The patient was monitored and arterial access controlled when the catheter was removed.There was no harm to the patient.The procedure was stopped to ensure patient safety.The patient has since received treatment and is stable with discharge date planned.

• Brand Name: DIAMONDBACK 360
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 7960238
• MDR Text Key: 123523076
• Report Number: 7960238
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 237441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 66