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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The distal driveshaft, saline sheath, and engaged guide wire section were returned for analysis without the oad handle.Examination of the saline sheath and driveshaft sections revealed them to have been destructively cut.The driveshaft filars were found to be stretched and there was adhered biological material on the driveshaft, crown, and exposed guide wire shaft at the tip bushing.Examination in the area of adhered material did not reveal any damage that would have contributed to the accumulation.There was no damage observed with the driveshaft and crown that would have contributed to the reported event.The guide wire exhibited numerous bends along the shaft.Examination of the remaining guide wire shaft did not reveal any additional damage that would have contributed to the reported event.At the conclusion of the device analysis investigation, the root cause of the reported event was unable to be confirmed.(b)(4).
Event or Problem Description
During a peripheral orbital atherectomy procedure using a csi orbital atherectomy device (oad), it was reported that a perforation occurred.The target lesion was heavily calcified, and was accessed through the groin.The lesion was treated using two passes with the oad, however the device then became stuck in the vessel.A cutdown was performed to remove the device, and the guide wire was noted to be kinked.Imaging was performed and a perforation was noted in the lateral plantar artery.The perforation was resolved without further intervention, and the patient was in stable condition 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 hwy 8 nw; saint paul MN 55112
• MDR Report Key: 7070544
• Report Number: 3004742232-2017-00145
• Device Sequence Number: 864572
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)190531(10)191750
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/30/2017

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: 05/31/2019
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 191750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2017
• Initial Report FDA Received Date: 11/30/2017
• 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