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

Model Number DBEC-125

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/01/2018

Event Type  Death  

Event Description

During percutaneous coronary intervention the csi diamondback 360 was inserted to the rca to debulk a calcified lesion in a typical fashion.During operation the device bogged down, became immobile in the right coronary artery.The device became lodged in the right coronary artery and multiple attempts were made to retrieve the device from the vessel but were unsuccessful.Manufacturer response for csi diamondback 360, diamondback 360 (per site reporter) pending.

Event Description

During percutaneous coronary intervention the csi diamondback 360 was inserted to the rca to debulk a calcified lesion in a typical fashion.During operation the device bogged down, became immobile in the right coronary artery.The device became lodged in the right coronary artery and multiple attempts were made to retrieve the device from the vessel but were unsuccessful.Patient tamponade, moved to higher level of care, later expired.Manufacturer response for csi diamondback 360, diamondback 360 (per site reporter).Pending.

Event Description

During percutaneous coronary intervention the csi diamondback 360 was inserted to the rca to debulk a calcified lesion in a typical fashion.During operation the device bogged down, became immobile in the right coronary artery.The device became lodged in the right coronary artery and multiple attempts were made to retrieve the device from the vessel but were unsuccessful.Patient tamponade, moved to higher level of care, later expired.Manufacturer response for csi diamondback 360, diamondback 360 (per site reporter) pending.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 7771622
• MDR Text Key: 116717196
• Report Number: 7771622
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2018

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 Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 227298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/14/2018; 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 31755 DA
• Patient Weight: 45