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

Model Number	DBP-EX-125SOL200
Medical Device Problem Codes	Material Separation (1562); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned with a driveshaft fracture at the distal edge of the crown.The guide wire was returned engaged in the distal driveshaft section.The distal and proximal fractured sections were sent for scanning electron microscopy (sem) analysis.Sem analysis identified evidence of fatigue striations on the fractured filar faces, indicating that the failure occurred while spinning in the presence of a high stress environment.The exact cause of the damage is unknown.Review of the log shows a low speed spin, four stalls on medium spin, one stall on glide and numerous attempts to start on glide with motor direction mismatch.This is possibly due to the crown being stuck when attempting to spin.It is possible that the stall events contributed to the driveshaft fracture, although this is not confirmed and the cause of the stall events is unknown.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
During procedure to treat a lesion in proximal anterior tibial artery, the diamondback 360 exchangeable orbital atherectomy device (oad) stalled during high-speed treatment and fractured beyond the crown of the oad resulting in dissection that was identified through imaging.The procedure was performed distal to proximal.The oad was removed, followed by percutaneous transluminal angioplasty (pta), and ballooning of the vessel was done to complete the procedure.In the physician's opinion, the dissection occurred due to oad and tortuosity of the vessel.

• 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; st. paul 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19461711
• Report Number: 3004742232-2024-00200
• Device Sequence Number: 6661993
• Product Code: MCW
• UDI-Device Identifier: 10852528005879
• UDI-Public: (01)10852528005879(17)241031(10)456109
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/04/2024

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: 10/31/2024
• Device Model Number: DBP-EX-125SOL200
• Device Catalogue Number: 7-10030-07
• Device Lot Number: 456109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown