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

Model Number	PRD-SC30-200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis conclusion: the oad was received at csi for analysis.Visual examination revealed a bend in the driveshaft near the proximal edge of the crown and fractured driveshaft filars within the saline sheath.One of the filars was protruding from the saline sheath.The fractured section was sent for scanning electron microscopy analysis, which revealed the driveshaft had fractured due to excessive torsional forces and fatigue.Although the root cause of the driveshaft damage and fractured filars is not conclusive, it is likely the result of localized, elevated stress levels applied to the driveshaft while spinning.The shaft damage prevented the oad from functioning as intended during functional testing.As the original guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the fracture.The device history record for this device lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event and the device met material, assembly, and quality control requirements prior to distribution.(b)(4).
Event or Problem Description
The stealth orbital atherectomy device (oad) was being analyzed for an issue that was not considered reportable.However, during failure analysis, a fracture was identified.

• 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
• MDR Report Key: 10270165
• Report Number: 3004742232-2020-00201
• Device Sequence Number: 3399414
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)230531(10)326222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: 05/31/2023
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 326222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1