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 Codes	Deformity/ Disfigurement (2360); No Code Available (3191)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a slow flow event occurred.The target lesion was treated using multiple passes with the oad at low speed.When imaging was performed, the flow was slower than anticipated.The lesion was treated again using multiple passes with the oad at medium speed, however the flow was still observed to be slow.Balloon angioplasty was performed and vasodilators were administered, however the slow flow was not resolved.Balloon angioplasty was performed again in multiple locations within the vessel, however the procedure was completed without resolution of the slow flow.The patient remained hospitalized, and an ulcer present on the toe of the patient prior to the procedure was noted to worsen.Amputation of the toe was performed on (b)(6) and the patient was discharged on (b)(6).Per the physician, the amputation was unrelated to the performance of any csi device.

• 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; saint paul MN 55112
• MDR Report Key: 7341288
• Report Number: 3004742232-2018-00059
• Device Sequence Number: 13838951
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)180831(10)136830
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 70056-03
• Device Lot Number: 136830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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; Disability
• Patient Age: 68 YR