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

Model Number	PRD-SC30-150
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id# (b)(4).
Event or Problem Description
A stealth peripheral gen2 orbital atherectomy device (oad) was used to treat a calcified, 90% stenosed lesion in the superficial femoral artery (sfa) and popliteal artery.After treatment, the oad became stuck on the guide wire.The oad, guide wire, and non-csi filter were all removed together, and a filter retrieval catheter was unable to be used.The content of the filter was possibly spilled during the retrieval.No damage was observed on the oad or guide wire.Biological emboli was observed in the vessel.A second non-csi filter was deployed distal to the embolization, and the emboli was captured.The patient was discharged home following the procedure.
Additional Manufacturer Narrative
The reported oad, guide wire, and non-csi filter were received for analysis.The non-csi filter was engaged on the guide wire, and the guide wire had been destructively cut.No additional damage was observed on the guide wire.Adhered biological material was observed on the distal and proximal edges of the driveshaft crown.Examination of the area of adhered material did not reveal any damage that would have contributed to the accumulation.A guide wire was passed through the oad driveshaft and met resistance near the adhered biological material.The driveshaft was cut proximal to the area of adhered material and the guide wire passed through the rest of the driveshaft and handle assembly with no resistance.The oad was tested, spun on all speeds, and functioned as intended.At the conclusion of the device analysis, the reported event of the device stuck on wire was confirmed.The report of embolization was unable to be confirmed through device analysis.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.The material inspection report for this guide wire 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.H6: results code: 4247 -suggested code is biological material present on device.(b)(4).

• 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: 11615980
• Report Number: 3004742232-2021-00109
• Device Sequence Number: 3156916
• Product Code: MCW
• UDI-Device Identifier: 10850000491288
• UDI-Public: (01)10850000491288(17)220630(10)331865
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 7-10059-03
• Device Lot Number: 331865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/16/2021
• 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