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

Model Number DBEC-125M

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2017

Event Type  malfunction  

Event Description

Csi arthrectomy 1.25 burr got stuck in distal peroneal branch.Physician made multiple attempts and removed the device.No harm to patient.Staff did not keep device.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 14740 kirby dr.; houston TX 77047
• MDR Report Key: 6676678
• MDR Text Key: 78684099
• Report Number: 6676678
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: DBEC-125M
• Device Catalogue Number: 7-10000-01
• Device Lot Number: 109389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 103