MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

Device Problem Failure to Advance (2524)

Patient Problems Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).

Event Description

A diamondback coronary orbital atherectomy device was selected for treatment of a lesion in the left anterior descending (lad) artery.The vessel was tortuous and had a calcium shelf located within the bend of the vessel.Radial access was obtained, and the oad was advanced to the lad artery.However, due to the tortuosity of the vessel, it could not be advanced into the lesion.The oad was removed from the patient, and a dissection was identified.The dissection flap caused the vessel to shut down, and balloon angioplasty was performed to expand the vessel.The vessel was successfully re-opened.Following resolution of the dissection, further complications arose, and the patient was sent for bypass surgery.The physician stated the issues experienced after resolution of the dissection were unrelated to csi product.The patient was reportedly fine after the surgery.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, mn ; 2591600
• MDR Report Key: 10137618
• MDR Text Key: 194619123
• Report Number: 3004742232-2020-00153
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211231(10)303510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

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 Expiration Date: 12/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 303510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR