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

Model Number	PRD-SC30-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).Csi id: (b)(4).
Event or Problem Description
The stealth peripheral orbital atherectomy device (oad) was operated for multiple treatment passes in the distal and proximal anterior tibial artery (at).When the oad was removed, it was noted to be stuck on the guide wire.The oad and wire were removed from the patient and the lesion was re-wired and balloon angioplasty was performed.Slow flow was then noted in the at and was resolved with balloon angioplasty and nitroglycerin.The patient was well at the conclusion of the procedure.The physician did not provide an opinion as to the cause of the slow flow.
Additional Manufacturer Narrative
The oad was received at csi for analysis.The device was returned with the guide wire engaged and stuck, confirming the report that the oad became stuck on the guide wire.The wire was removed with resistance.A visual analysis revealed adhered biological material on the driveshaft filars and on the engaged guide wire section that was located under the driveshaft tip bushing area.Examination did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulation is unknown.When tested the device functioned as intended.The report of "slow/no flow" could not be confirmed through analysis.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 prior to distribution.Results code: 4247 - suggested code is biological material present on device conclusion code: 4316 - suggested code is cause traced to procedure.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 MN 55112
• MDR Report Key: 12688982
• Report Number: 3004742232-2021-00357
• Device Sequence Number: 11793992
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)230331(10)375143-1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 375143-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 91