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

Model Number	DBP-150CLASS145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device and guide wire were discarded by the facility; therefore, an analysis of the actual complaint devices is not possible.The device history record for this oad lot number and the material inspection report for the guide wire lot number have 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).Discarded by facility.
Event or Problem Description
It was reported that during a peripheral orbital atherectomy procedure, a perforation occurred.The target lesion was located in the peroneal artery.The physician advanced a csi viperwire flextip guide wire across the lesion and loaded a csi orbital atherectomy device (oad) onto it.An unknown number of runs were completed, but post-atherectomy angiography revealed that the guide wire appeared to have a winding appearance.The oad and guide wire were successfully removed from the patient and the physician then performed balloon angioplasty.Post-angioplasty angiography revealed a perforation.No additional intervention was performed to resolve the perforation.It could not be determined whether or not the csi guide wire or oad contributed to the perforation.Additional information was requested, but was denied by the facility.

• 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: 6058113
• Report Number: 3004742232-2016-00126
• Device Sequence Number: 867638
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)180430(10)157736
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/25/2016

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: 04/30/2018
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: DBP-150CLASS145
• Device Lot Number: 157736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2016
• Initial Report FDA Received Date: 10/26/2016
• 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: Other; Required Intervention