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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oad was returned with the guide wire engaged.Significant resistance was noted when attempting to remove the guide wire.Visual analysis confirmed fractured driveshaft filars at the proximal side of the crown, however, the driveshaft was not fully separation.Scanning electron microscope analysis of the fractured filars revealed evidence of fatigue which is an indication that the driveshaft was spun in a high stress environment.Diagnostic analysis identified a stall event.The exact root cause of the reported events were unable to be determined.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
A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat the common femoral artery.The device was retracted to the lesion in the common iliac artery.Two treatments on low speed were performed.When changing the speed to medium, the oad stopped spinning.The oad was difficult to remove and seemed to be stuck on the viperwire advance guide wire.The oad and guide wire were removed.Damage was observed on the driveshaft near the crown.A new guide wire was used and the procedure was complete with percutaneous transluminal angioplasty.The patient was stable.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16612264
• Report Number: 3004742232-2023-00079
• Device Sequence Number: 5131809
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)240131(10)416973-1
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/24/2023

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: 01/31/2024
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 416973-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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
• Patient Sex: Male