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

Model Number	DBP-EX-200SOL145
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was used for treatment of a heavily calcified lesion in the common femoral artery (cfa)/superficial femoral artery (sfa) bifurcation via femoral up-and-over approach.The iliac bifurcation was steep, and the oad crown could not be advanced to the other side.Pulling back the sheath and advancing the crown and the sheath at the same time resolved the issue.The treatment was completed.During crown removal over the wire from the right iliac, the crown detached.A snare catheter was used to retrieve the detached crown.There were no further complications to the patient.In the opinion of the physician, crown damage might have occurred while attempting to advance the crown up and over the iliac bifurcation.The patient was stable.
Additional Manufacturer Narrative
The diamondback 360 exchangeable peripheral orbital atherectomy device (oad) was returned with a driveshaft fracture at the distal side of the crown.The distal fractured section was returned engaged over a viperwire advance coronary guide wire with flex tip.The use of a coronary guide wire with a peripheral oad is inconsistent with the diamondback 360 exchangeable peripheral orbital atherectomy system instructions for use (ifu) manual.Diagnostic analysis identified stall and bog events during the procedure, however, it could not be confirmed if these events are related to the driveshaft fracturing.Scanning electron microscopy analysis of the fractured filar faces identified fatigue striations, indicating that the failure occurred while spinning in a high-stress environment, though, the exact root cause of the fracture was unable to be determined.The exchangeable oad ifu states "only use the approved csi viperwire advance 0.014-inch (0.3556 mm) × 335-cm guide wires for 75cm and 145 cm length csi crown and shaft configurations.Only use the approved csi viperwire advance 0.014-inch (0.3556 mm) x 475 cm guide wires for 180 cm and 200 cm length csi crown and shaft configurations.See table 5 and table 6 for the appropriate guide wire to use based on the oad shaft configuration.Follow csi's instructions related to guide wire use." 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: 14176.

• Brand Name: DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19324179
• Report Number: 3004742232-2024-00184
• Device Sequence Number: 2582552
• Product Code: MCW
• UDI-Device Identifier: 10852528005848
• UDI-Public: 01108525280058481725083110502639
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/15/2024

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: 08/31/2025
• Device Model Number: DBP-EX-200SOL145
• Device Lot Number: 502639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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 Sex: Female