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

Model Number	DBE-200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.Visual examination revealed the driveshaft was damaged and severely stretched at the proximal and distal edge of the crown.The crown was detached and not returned for analysis.Scanning electron microscopy analysis of the driveshaft crown bond location showed the presence of residual solder, indicating the crown had been sufficiently attached at one point.The device data log did not reveal any issues that would have contributed to the reported events.When tested for functionality, the oad functioned as intended.At the conclusion of the device analysis investigation, the report that the oad could not cross the lesion could not be confirmed through analysis.The root cause of the detached crown 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.Csi id: (b)(4).
Event or Problem Description
The stealth peripheral orbital atherectomy device (oad) was unable to advance to through the vessel and the procedure was completed with a smaller sized crown.Upon receipt of the oad for analysis, the crown was found to be detached.Per csi field staff, there were no fragments left in the patient's body.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 11580873
• Report Number: 3004742232-2021-00099
• Device Sequence Number: 4182254
• Product Code: MCW
• UDI-Device Identifier: 10850000491349
• UDI-Public: (01)10850000491349(17)221031(10)348771-1
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: DBE-200
• Device Catalogue Number: 7-10059-09
• Device Lot Number: 348771-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1