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

Model Number	DBP-150SOLID200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad and guide wire were returned to csi for analysis.A visual examination of the driveshaft and crown area confirmed that the driveshaft was fractured.When the control knob was in the forward position damage was observed near the nose cone.The fragment was returned to csi, however was lost during analysis and could not be examined further.The returned guide wire was able to pass through the remaining driveshaft and handle assembly without issue.Scanning electron microscopy analysis of the fractured filars showed evidence of fatigue which is an indication that the driveshaft was spun in a high stress environment.Review of the device data log identified four stall events.At the conclusion of the device analysis investigation, the report that the driveshaft fractured was confirmed.It is possible that the stall events were related to spinning the device through a difficult area, which would have contributed to the elevated stress levels and eventual driveshaft fracture, however the root cause of the fracture remains undetermined.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
Difficulty was encountered advancing a 6 french sheath through the calcified aortic bifurcation, and the sheath was instead placed in the proximal right common iliac.The diamondback coronary orbital atherectomy device (oad) was used to treat the common femoral and proximal superficial femoral artery on low speed.The oad was operated on medium speed and an usual noise was observed and the oad stopped spinning.During attempts to remove the oad the device became stuck inside the sheath at the aortic bifurcation.The oad was pulled and the driveshaft fractured.A non-csi guide wire was inserted to maintain wire access and a balloon was inserted to inflate the crown into place in the sheath.The sheath was removed and the viperwire and non-csi wire remained in vivo.The procedure was completed with a second sheath and balloon angioplasty.There was no harm to the patient.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 13523641
• Report Number: 3004742232-2022-00036
• Device Sequence Number: 11858322
• Product Code: MCW
• UDI-Device Identifier: 10850000491226
• UDI-Public: (01)10850000491226(17)230831(10)392551-1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: DBP-150SOLID200
• Device Catalogue Number: 7-10057-06
• Device Lot Number: 392551-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female