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

Model Number	PRD-SC30-150
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of the "event" is the date the analysis of the device was completed.Device analysis conclusion: the oad was received at csi for analysis with stent-like material wrapped around the driveshaft.Analysis did not identify any damage that may have contributed to the accumulation.The data log was read, and the report that the oad stalled was confirmed.It is hypothesized that the stent material accumulation is related to the reported stall.However, that could not be conclusively confirmed.The root cause of the stent material on the crown is related to use not consistent with ifu.It should be noted that the stealth 360 gen2 peripheral orbital atherectomy system instructions for use manual states, "use of the oas is contraindicated for use.[when] the target lesion is within a bypass graft or stent." the opinion of the physician was that a stent was not removed from the patient.However, the analysis findings indicate the material is likely from a stent.Therefore, csi is reporting this event in good faith.Conversations with the physician are ongoing.If additional information is received, a supplemental mdr will be submitted.Csi id: (b)(4).
Event or Problem Description
Material resembling a stent was observed on the stealth peripheral orbital atherectomy device (oad) during device analysis for a non-reportable complaint (device stall and resistance during removal).It appeared during analysis that the oad had inadvertently contacted a pre-existing stent.Apparently, the stent was inadvertently extracted when the oad was removed from the patient.

• 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
• MDR Report Key: 12583163
• Report Number: 3004742232-2021-00336
• Device Sequence Number: 14275116
• Product Code: MCX
• UDI-Device Identifier: 10850000491288
• UDI-Public: (01)10850000491288(17)230228(10)367649-1
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 7-10059-03
• Device Lot Number: 367649-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/06/2021
• 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: Other