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

Model Number	DBP-150CLASS145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).
Event or Problem Description
A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat the first third of the severely calcified and totally occluded posterior tibial artery (ta).Following treatment, the oad was advanced and the crown became detached from the driveshaft.The crown became fractured into pieces and was unable to be retrieved from the chronically occluded segment of the posterior ta.No intervention was performed.The procedure was aborted.The patient was stable.
Additional Manufacturer Narrative
The oad was returned to csi for analysis.Visual inspection confirmed the crown was detached from the driveshaft, which is consistent with the reported information.Scanning electron microscopy analysis confirmed that the crown was soldered to the driveshaft during manufacturing.No anomalies were observed in the device data log; it indicates the oad did not stall or otherwise malfunction during use.The oad functioned as intended during testing, however the physical analysis remains incomplete since the crown could not be analyzed.Abbott requested films of the procedure, but these were not released and therefore could not be reviewed during the investigation.It remains unclear whether procedural or patient factors contributed to the crown separation.At the conclusion of the investigation, the root cause of the crown separation could not be conclusively 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY 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: 17573096
• Report Number: 3004742232-2023-00213
• Device Sequence Number: 8223144
• Product Code: MCX
• UDI-Device Identifier: 10850000491240
• UDI-Public: (01)10850000491240(17)240831(10)445056-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 08/31/2024
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: 7-10057-08
• Device Lot Number: 445056-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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: Unknown