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

Model Number	DBE-150
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
A stealth gen2 peripheral orbital atherectomy device was selected for treatment of a 99% stenosed, severely calcified lesion in the mid to distal anterior tibial artery.The artery was not tortuous and 2.0mm in diameter.Treatment was started on low speed, however, the oad did not pass through the lesion.Medium speed was selected, and additional force was applied.The crown stayed in place proximal to the lesion, however, the distal tip of the driveshaft advance through the lesion.The crown was observed to be detached.A balloon was inflated to 2 atms and used to retrieve the crown from the vessel.Additional balloon angioplasty was used to complete the procedure for a good result.
Additional Manufacturer Narrative
The reported oad was received for analysis.The driveshaft crown was detached.No additional damage was visually observed on the oad.Scanning electron microscopy (sem) analysis of the solder bond location found solder residue with rotational displacement.This damage likely occurred from spinning within the detached crown during the procedure.A review of the device data did not identify evidence that the device was traversed with excessive force.Analysis was unable to confirm that the solder had been sufficiently wetted to the driveshaft filars.Therefore, it is concluded that the crown solder bond did not meet the intended use for the oad, and the root cause of the detached crown is considered to be a manufacturing issue due to an insufficient solder bond.A guide wire was passed through the oad driveshaft and handle with no issue.The oad was tested, spun on all speeds, and functioned as intended.At the conclusion of the device analysis, the reported event of the crown detaching from the driveshaft was 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).

• Brand Name: STEALTH PERIPHERAL 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: 11575479
• Report Number: 3004742232-2021-00094
• Device Sequence Number: 3598928
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)220430(10)324129
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: 04/30/2022
• Device Model Number: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 324129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/02/2021
• 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: Required Intervention