MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (CSI) DIAMONDBACK; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number DBP-EX-125MIC142

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2022

Event Type  malfunction  

Event Description

Diamondback atherectomy device opened and used on sterile field during procedure under guidance of csi rep.The device worked until surgeon tried to use it on the medium setting.After troubleshooting was unsuccessful, the device was removed and replaced with a new diamondback 360 atherectomy system.The defective device was taken by csi rep to be reviewed by the company.The new device was used with no further issues.

• Brand Name: DIAMONDBACK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (CSI); 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 15174057
• MDR Text Key: 297326121
• Report Number: 15174057
• Device Sequence Number: 1
• Product Code: MCW
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-EX-125MIC142
• Device Lot Number: 424354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30660 DA
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: Black Or African American