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

Model Number	DBE-150
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oad was returned to csi for analysis.Analysis revealed a hole in the saline sheath.During functional testing, fluid was observed leaking from the damaged site.There were no other damages observed.The root cause of the damage could not conclusively be determined.When tested, the oad spun as intended.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 saline sheath of the stealth 360 peripheral orbital atherectomy device (oad) was observed to be damaged upon removal of the oad at the end of the procedure.Saline fluid was leaking outside of the sterile field.It was indicated there was enough saline encapsulated in the system to allow for smooth removal.The patient was in stable condition following 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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15808831
• Report Number: 3004742232-2022-00267
• Device Sequence Number: 17896299
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)230731(10)387717-1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/16/2022

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 Expiration Date: 07/31/2023
• Device Model Number: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 387717-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Race: Asian