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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolus (1830)
Date of Event	10/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the facility; therefore, an analysis of the actual complaint device is not possible.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
It was reported that during a peripheral orbital atherectomy procedure, the lateral plantar artery shut down.The target lesion was located in the proximal superficial femoral artery (sfa).The physician advanced a csi viperwire guide wire across the lesion and loaded a csi orbital atherectomy device (oad) onto it.The physician completed atherectomy, but the patient started to complain of leg pain.Angiography revealed emboli in the lateral plantar artery and the vessel shut down.The physician was able to aspirate the emboli from the artery and resolve the arterial vessel shut down.The physician then completed the intervention by performing balloon angioplasty and stent deployment in the sfa.The patient status remained stable throughout the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 6092599
• Report Number: 3004742232-2016-00129
• Device Sequence Number: 775120
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)180831(10)168633
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2016

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: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 168633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2016
• Initial Report FDA Received Date: 11/10/2016
• 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: 63 YR