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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Perforation (2001); Pseudoaneurysm (2605)

Event Date 10/26/2018

Event Type  Injury  

Event Description

Patient taken to cardiac cath in which there was a right coronary artery (rca) laceration with perforation.Patient was taken to or for emergent surgery for entry sternotomy, evacuation and debridement of the false aneurysm, and control of hemorrhage from the right coronary artery from the take-off of the acute marginal branch back toward the ostium of the right coronary bypass to the distal right coronary with saphenous vein.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC; 1225 old highway 8 nw; st. paul MN 55112
• MDR Report Key: 8607255
• MDR Text Key: 144950917
• Report Number: 8607255
• 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: 05/10/2019

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
• Device Model Number: DBEC-125
• Device Lot Number: 234237
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 23360 DA
• Patient Weight: 44