MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH 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	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis.The driveshaft crown was detached and not returned.The driveshaft filars were stretched and elongated at the crown location.Scanning electron microscopy of the driveshaft crown bond location showed evidence of solder on the driveshaft filars in the crown bond location.This indicates a crown had been attached at one point.It is possible that the driveshaft filars became damaged and deformed within the vessel resulting in the crown detachment; however, the exact root cause of the crown detachment is unknown.The oad was tested, spun on all speeds, and functioned as intended.At the conclusion of the device analysis, the reported event was 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
A stealth peripheral orbital atherectomy device (oad) was selected for treatment of a lesion in the superficial femoral artery.The lesion was moderately calcified, and the vessel was 6 mm in diameter with no tortuosity.The oad looked odd, but treatment continued and the oad was inserted into the patient.The crown was difficult to see under fluoroscopy.The oad was removed from the patient, and a sharp angle where the crown would have been located was observed.Upon examination, the crown did not appear to be attached to the driveshaft.It was not known when the crown became detached from the driveshaft or if it was attached prior to introduction to the patient.It was confirmed that no fragments remained in the patient.The oad was unable to be re-advanced on the guide wire.A second oad was used to complete the procedure with no patient complications.

• Brand Name: STEALTH 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: 10636879
• Report Number: 3004742232-2020-00301
• Device Sequence Number: 16907648
• Product Code: MCW
• UDI-Device Identifier: 10850000491349
• UDI-Public: (01)10850000491349(17)220228(10)314640
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/06/2020

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: 02/28/2022
• Device Model Number: DBE-200
• Device Catalogue Number: 7-10059-09
• Device Lot Number: 314640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 54