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

Model Number	DBP-EX-150CLA145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).
Event or Problem Description
Occluded lesions in the superficial femoral (sfa), posterior tibial (pt) and anterior tibial (at) arteries were crossed from an antegrade approach.The at was accessed via the pedal arch and a diamondback peripheral exchangeable orbital atherectomy device (oad) was used to treat the pt.Glideassist was used to navigate the oad around the pedal arch and treatment was performed in the at.When treatment with the oad was completed, glideassist was activated to remove the device, however it was stuck in the vessel.Multiple attempts were made to remove the device, but they were unsuccessful.Cut down surgery was performed to remove the device and the patient was stable following the procedure.
Additional Manufacturer Narrative
The oad and guide wire were received at csi for analysis.There was no damage or abnormalities observed that would have contributed to the reported event.The oad crown was measured and found to be within specification.The driveshaft of the oad and the guide wire are separated and the distal guide wire spring tip section was not returned.Scanning electron microscopy analysis determined that the driveshaft was cut, and the wire was pulled to failure.This damage is likely due to handling and removal attempts during the procedure and is not considered a contributing factor to the reported event.Analysis of the device data log identified multiple stall events.It is possible that the stall events may have contributed to the reported event, however this was not confirmed.The root cause of the stall events is undetermined.At the conclusion of the device analysis investigation, the report that the device became stuck in the vessel could not be confirmed.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 11724969
• Report Number: 3004742232-2021-00156
• Device Sequence Number: 17031666
• Product Code: MCW
• UDI-Device Identifier: 10852528005909
• UDI-Public: (01)10852528005909(17)221231(10)358769
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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 Expiration Date: 12/31/2022
• Device Model Number: DBP-EX-150CLA145
• Device Catalogue Number: 7-10030-10
• Device Lot Number: 358769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR