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

Model Number	DBP-125SOLID145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During treatment of a heavily calcified long lesion in the anterior tibial artery, the crown of the diamondback 360 peripheral orbital atherectomy device (oad) became stuck in the vessel and stalled.The crown and the control knob did not move one to one and the control knob only moved and jumped back.8-10 short treatments were performed in three regions of the anterior lesion with a combination of low and medium speed per treatment.Nitroglycerin was administered to the patient and troubleshooting was done by both locking and unlocking the crown advancer knob with a representative's assistance via phone.The oad was removed from the patient's body and upon removal, the oad appeared fine with no damage.Angioplasty was performed to complete the procedure.In the physician's opinion, the issue was likely due to severe calcium buildup and a prolonged time of treatment due to the disease severity.The patient was stable.
Additional Manufacturer Narrative
The investigation is ongoing.A final report will be submitted once the investigation is complete.Csi id: (b)(4).
Additional Manufacturer Narrative
The diamondback peripheral orbital atherectomy device (oad) was returned for analysis.Review of the data log identified several stall events during the procedure confirming the reported complaint of stall.The cause of the stall event is undetermined.There was no damage observed to the driveshaft or handle assembly that would have contributed to the reported complaints.Also, the crown diameter was measured and met drawing specification.As the guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the reported complaint.An in-house 0.014" test wire passed through the device with resistance due to the shipping damage.The control knob was traversed and observed moving 1:1 with the crown.When functional testing was performed, the oad functioned as intended.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 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old highway 8 nw; st. paul, MN 55112
• MDR Report Key: 18896304
• Report Number: 3004742232-2024-00128
• Device Sequence Number: 7682942
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)250531(10)489273-1
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 05/31/2025
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 489273-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown