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

Model Number	PRD-SC30-125
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Race was indicated as "other." return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
The stealth orbital atherectomy device (oad) was used for treatment of lesions in the superficial femoral artery and anterior tibial artery (at).During treatment in the at, the device stalled and became stuck in the vessel.Unsuccessful attempts to remove the device included angioplasty, alternate access, and snares.The driveshaft of the oad was cut, and a sheath was advanced over the driveshaft, but the device could not be removed.The patient was then taken by ambulance to a hospital, and surgical removal was successfully performed.
Additional Manufacturer Narrative
Device analysis conclusion: the oad handle was returned to csi with a portion of the driveshaft still intact.The remainder of the driveshaft was not returned, which is consistent with the details reported to csi.Review of the device data log revealed stall events during the procedure.It is possible that the stall events are related to the report that the oad became stuck in the vessel; however, this could not be confirmed through analysis.The cause of the stall events remains unknown.The oad operated as intended during functional testing.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).

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 11831871
• Report Number: 3004742232-2021-00178
• Device Sequence Number: 4443661
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)220831(10)340115
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 340115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/06/2021
• 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