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

Model Number	PRD-SC30-200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date received by manufacturer: the report of the event itself was provided to csi postmarket surveillance on 10/27/2021.However, the specific reason the procedure was aborted was not provided until (b)(6) 2021.Aware date of reportable information is (b)(6) 2021.(b)(4) the oad and guidewire were returned to csi for analysis.There was no damage observed on the driveshaft or handle assembly that would have contributed to the reported events.The device was returned with the guide wire engaged.The wire was entrapped in the oad, which confirmed the report that the device became stuck on the guidewire.The wire was removed with resistance.Analysis revealed adhered biological material on the proximal and distal edge of the driveshaft crown.Examination did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulation is unknown.The report that the device became stuck in the vessel could not be confirmed by analysis.However, the report that the device became stuck on the wire was confirmed.The oad functioned as intended during 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.(b)(4).
Event or Problem Description
A stealth orbital atherectomy device (oad) was advanced into the superficial femoral artery for treatment of a chronic total occlusion.As the crown was advanced near the proximal portion of the lesion, the crown became entrapped in the vessel and stopped spinning.This issue recurred three times, and atherectomy was aborted.The oad became stuck on the guide wire, and the wire and oad were removed together.The procedure was then aborted since the lesion could then not be crossed with another guide wire.The patient was moved to recovery.The physician plans to bring the patient back in three weeks for another intervention.

• Brand Name: STEALTH PERIPHERAL 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 12893837
• Report Number: 3004742232-2021-00400
• Device Sequence Number: 17009129
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)230331(10)371856-1
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/30/2021

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: 03/31/2023
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 371856-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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 Sex: Unknown