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

Model Number	DBP-150SOLID200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis results: the oad was received at csi for investigation.Examination of the oad identified a fractured driveshaft filar, which was wrapped in the saline sheath.Scanning electrom microscopy (sem) analysis of the fractured filar faces revealed secondary wear damage, but no signs of potential fatigue striations could be seen.Although the root cause of the driveshaft damage is not conclusive, it is likely the result of localized, elevated stress levels applied to the driveshaft while spinning.When functionally tested, the oad operated as intended.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 diamondback peripheral orbital atherectomy device (oad) was used to perform a procedure on (b)(6) 2020.A non-reportable issue was reported with the oad.The procedure was completed with a second oad.The delay was minimal, and there were no patient complications.Upon completion of the device analysis on (b)(6) 2020, a filar fracture was identified.

• Brand Name: DIAMONDBACK PERIPHERAL 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: 9986248
• Report Number: 3004742232-2020-00127
• Device Sequence Number: 17253891
• Product Code: MCX
• UDI-Device Identifier: 10852528005367
• UDI-Public: (01)10852528005367(17)210831(10)284318
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 08/31/2021
• Device Model Number: DBP-150SOLID200
• Device Lot Number: 284318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1