MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	DBP-200SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id# (b)(4).
Event or Problem Description
A diamondback peripheral orbital atherectomy device (oad) was selected for treatment via femoral access.During an attempt to advance the oad to the lesion, the oad became stuck inside of the sheath at the aortic bifurcation.The oad was pulled back, and it was observed that the oad driveshaft had fractured distal to the crown.The fractured segment was removed with no additional patient complications reported.
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.The driveshaft was fractured at the distal edge of the crown.No additional damage was observed on the oad.Scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.It was hypothesized that this driveshaft underwent extreme flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.The device data log indicated the device was possibly stuck, followed by a 9 second spin.It is possible that an attempt was made to spin out of the stuck condition in the reportedly tight bend.This could have fatigued the driveshaft, ultimately resulting in a fracture.However, this was not able to be conclusively confirmed, and the root cause of the fracture was unable to be undetermined.A guide wire was passed through the oad with no issue, and the oad functioned as intended.At the conclusion of the device analysis, the reported fracture event 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: DIAMONDBACK 360 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: 12303385
• Report Number: 3004742232-2021-00285
• Device Sequence Number: 3612138
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)221031(10)349965-1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/18/2021

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: 10/31/2022
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 349965-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1