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

Model Number	DBE-150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned without the guidewire to csi.Visual analysis did not reveal any damage to the saline sheath of handle assembly.The crown and saline sheath diameters were measure and met specification.As there were no device issues identified during analysis, patient anatomy or other external factor may have contributed to the difficulties advancing the device.When tested, the device functioned as intended.The device expiration date is 04/30/2024.Csi id: (b)(4).
Event or Problem Description
The stealth 360 peripheral orbital atherectomy device (oad) was advanced to the superficial femoral artery where a proximal occlusion was treated.The oad could not advance further over a tortuous iliac bifurcation.The oad was removed and replaced.When the device was removed, the mid/distal portion of the saline shaft was noted to be damaged.The flow of saline to the tip of the oad was considered sufficient to avoid patient injury during the procedure.

• Brand Name: STEALTH 360 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: 15327767
• Report Number: 3004742232-2022-00208
• Device Sequence Number: 5375286
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)240430(10)431056-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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 Model Number: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 431056-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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
• Patient Sex: Unknown