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

Model Number	DBP-200CLASS145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received for analysis.When tested, the device was found to function as intended with no anomalies noted.Adhered biological material was observed on the driveshaft and crown, however no damage to the device was observed which would have contributed to the accumulation.At the conclusion of the failure analysis investigation, the cause of the reported event was unable to be confirmed.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.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection occurred.The target lesion was 90% stenosed and located in the common femoral artery.The lesion was treated using the oad on low speed, however when the device was operated on high speed it would continuously lose power.When the device would regain power, the crown would resume spinning.The device was replaced and treatment was continued.After use of the second oad, a dissection was noted.A stent was placed to resolve the dissection and the patient was stable following the procedure.

• 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: 7249456
• Report Number: 3004742232-2018-00025
• Device Sequence Number: 14028507
• Product Code: MCW
• UDI-Device Identifier: 10852528005268
• UDI-Public: (01)10852528005268(17)190430(10)189218
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: DBP-200CLASS145
• Device Catalogue Number: DBP¿200CLASS145
• Device Lot Number: 189218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/07/2018
• 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