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

Model Number DBP-EX-125SOL145

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/10/2021

Event Type  malfunction  

Event Description

Narrative from staff: surgeon was doing an atherectomy with csi and the csi device was not working properly.The device kept blinking, surgeon attempted to troubleshooting with csi representative on the phone and was unable to fix the problem.So, the device was removed from the patient and a new device was opened.Narrative from operative report: the csi 1.25 device was brought into position.The common carotid was clamped, and the csi atherectomy was performed with several 30-minute runs at slow, medium, and high speed, after which the 1.25 device was removed.The 2.0 device was used to treat the stenosis once again at 30-second runs at low, medium, and high speed, several runs each.The device was removed.Manufacturer response for catheter, peripheral, atherectomy, diamondback peripheral (per site reporter): unknown.

• Brand Name: DIAMONDBACK PERIPHERAL
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 13141610
• MDR Text Key: 283087437
• Report Number: 13141610
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: 7-10030-02
• Device Lot Number: 385543
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Male
• Patient Weight: 118 KG