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

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation of Vessels (2135)

Event Date 07/26/2022

Event Type  Injury  

Event Description

During the second treatment of the dorsalis pedis (dp) artery with the diamondback exchangeable orbital atherectomy device (oad), the crown jumped backwards and stopped spinning.The oad was removed, and a perforation of the dp artery was observed.Balloon angioplasty was attempted to resolve the perforation.A non-csi balloon was unable to cross the lesion and became stuck on the viperwire advance guide wire.Another attempt was made with a different non-csi balloon, however, the issue persisted.The wire and balloon were removed and a kink proximal of the spring tip was observed on the wire.No further intervention was performed to resolve the perforation.The patient was stable, and the perforation will continue to be monitored.

Manufacturer Narrative

The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.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.Related manufacturer report number: 3004742232-2022-00196.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15282684
• MDR Text Key: 298475612
• Report Number: 3004742232-2022-00197
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• 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
• Date Manufacturer Received: 07/26/2022
• 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): Required Intervention
• Patient Sex: Female