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

Model Number	DBP-EX-125MIC145
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Related manufacturer report number: 3004742232-2022-00197.Csi id: (b)(4).
Additional Manufacturer Narrative
The oad was returned to csi for analysis.During the investigation, device stall events were observed.Further analysis revealed adhered biological mater on the driveshaft crown which prevented a test wire from passing through.Analysis did not identify any damage that may have contributed to the accumulating material.The morphology and exact root cause of the accumulated biological material was unable to be determined.The reported event of crown jumping and perforation were unable to be confirmed.When tested, the device functioned as intended.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: 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: 15284177
• Report Number: 3004742232-2022-00196
• Device Sequence Number: 7111096
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)230430(10)375988
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 375988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female