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

Device Problem Material Separation (1562)

Patient Problems Angina (1710); Foreign Body In Patient (2687)

Event Date 10/02/2020

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.The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.Related to oad used in the same procedure, reported under mdr 3004742232-2020-00344.Additional patient information has been requested, but has not yet been received.If additional information is received a supplemental report will be submitted.Csi id: (b)(4).

Event Description

Orbital atherectomy was performed with a diamondback coronary orbital atherectomy device (oad), and the oad driveshaft fractured.The lesion was located in the left circumflex artery and the vessel was extremely tight with moderate to severe tortuosity.The viperwire guide wire was pulled in an attempt to remove the fragment, however an angiogram revealed that the guide wire would not move and that the spring tip had also fractured.The spring tip was left in the patient.The patient was discharged in stable condition, but with persistent angina.As of 29-oct-2020 plans for a follow-up procedure to remove the fragment are under review.

• 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 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 10904706
• MDR Text Key: 218268636
• Report Number: 3004742232-2020-00382
• Device Sequence Number: 1
• Product Code: MCX
• 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: 11/25/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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