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

Model Number	DBP-125MICRO145
Medical Device Problem Codes	Entrapment of Device (1212); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
During treatment of a 100% stenosed lesion in the anterior tibial artery, the diamondback peripheral orbital atherectomy device (oad) was noted to audibly change pitch.When the treatment results with the oad were deemed satisfactory, the oad was retracted but was stuck on the viperwire guide wire and was unable to be removed without also moving the wire out of position.The oad and wire were removed together.Upon removal, tissue was noted on the crown of the oad.The physician was unable to rewire the vessel successfully in the true lumen, and the procedure was delayed by thirty minutes.Balloon angioplasty was performed to complete the procedure, however the balloon was only able to advance a partial distance through the vessel.There were no patient complications and the patient was discharged following the procedure.
Additional Manufacturer Narrative
The reported oad was received for analysis along with the guide wire utilized during the procedure.The guide wire was engaged in the oad, and significant resistance was felt upon removal.Adhered biological material was observed to be present on the guide wire core shaft and under the oad crown and tip bushing.There was no damaged identified which may have contributed to the material accumulation.Although the root cause of the accumulated material is unknown, it is hypothesized that the oad driveshaft became stuck on the guidewire after seizing due to biological material accumulation.The accumulation may have contributed to the report that the oad exhibited an audible change in pitch, however this could not be confirmed.At the conclusion of the device analysis investigation, the report of the device becoming stuck on the guide wire was confirmed, however the report of an audible pitch change could not be confirmed.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.Csi id: (b)(4).

• 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; st. paul, mn MN 55112
• MDR Report Key: 8781574
• Report Number: 3004742232-2019-00178
• Device Sequence Number: 1977266
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210331(10)263870
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 263870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1