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

Model Number	PRD-SC30-200
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis.The oad driveshaft near the lap weld was overloaded.It was possible the overloaded driveshaft may have been a contributing factor in the reported event, however, the root cause of the damage was unable to be determined.Driveshaft overloading is an indication that the spinning driveshaft met sudden resistance bringing it to a stall condition.No other damage on the driveshaft or handle assembly was observed.Blood was observed within the saline sheath.The fluid accumulation is not considered a contributing factor to the reported event.A guide wire was unable to pass through the overloaded area of the driveshaft.The oad was tested, spun on all speeds and functioned as intended.The control knob was traversed, and the crown moved at a 1:1 ratio with the control knob.The oad was turned on and off numerous times without any issue or popping noise observed.At the conclusion of the device analysis, the reported event of a popping noise and the control knob and crown moving independently was not able to be conclusively confirmed.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
A stealth orbital atherectomy device (oad) was selected for treatment of a heavily stenosed lesion in the common femoral artery (cfa) via brachial access.The oad was positioned using significant force, and as the oad engaged the lesion, a popping sound was heard.The oad was turned off, and it was noted that the control knob and crown were not moving at a 1:1 ratio.The oad and guide wire were removed, and the crown was observed to move independently of the control knob.The lesion was difficult to rewire, and the procedure was delayed by greater than 30 minutes.The procedure was completed with balloon angioplasty, and no patient adverse events were reported.

• 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: 11046535
• Report Number: 3004742232-2020-00415
• Device Sequence Number: 1307754
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)230131(10)306429
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: 01/31/2023
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 306429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 68