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

Model Number	PRD-SC30-200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No code available - suggested code: procedural delay.The oad was received at csi for analysis without protective packaging.Visual examination of the saline sheath revealed axial compression damage and deformation at the distal end of the saline sheath.Although the root cause of the saline sheath damage is undetermined, it is hypothesized that the damage is a result of applying excessive tension to the shaft and system during an attempt to remove the device and guide wire or the result of attempting to advance the device through a tight location.It is possible the saline sheath damage may have contributed to the reported event; however, this could not be confirmed through analysis.The oad driveshaft did not exhibit any damage that would have prevented a guidewire from passing through, and an in-house test wire was advanced into the driveshaft and handle assembly without resistance.As the original guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the reported complaint.At the conclusion of the failure analysis investigation, the reported driveshaft kink and inability to advance the guide wire through the oad could not be confirmed through 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.(b)(4).
Event or Problem Description
The sheath of the stealth orbital atherectomy device was kinked, and the guide wire could not be advanced through it.The procedure was completed with a second oad.The procedure was delayed by 30 minutes or more due to the issue.

• Brand Name: STEALTH ORBITAL ATHERECTOMY DEVICE
• Common Device Name: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 9667970
• Report Number: 3004742232-2020-00027
• Device Sequence Number: 3445042
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)220131(10)256255
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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: 01/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 256255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1