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

Model Number	DBE-150
Medical Device Problem Codes	Entrapment of Device (1212); Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
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 a procedure, a device malfunction occurred with the stealth peripheral orbital atherectomy device (oad).The initial target lesion was a 100% stenosed, 100mm in length, in the anterior tibial artery with a diameter of 3.5 mm.The initial lesion was treated with multiple passes of the device.The oad became stuck on the guide wire and the oad and guide wire were removed together resulting in loss of wire access.Re-wiring was performed for a second lesion located in the posterior tibial artery, resulting in a procedural delay of over 30 minutes.Prior to atherectomy of the second lesion, the sheath covering the driveshaft of the oad was noted to be loose.The oad was removed, and the second vessel was ballooned without using atherectomy.There were no patient complications from the procedure reported and the patient was discharged in stable condition.
Additional Manufacturer Narrative
The reported oad was received for analysis along with the guide wire utilized during the procedure.Adhered biological material was observed on the distal edge of the driveshaft crown and there was no damage observed with the oad.Upon examination of the guide wire, the proximal spring tip coil was stretched but it was determined that the stretching would not have contributed to the reported event.The guide wie passed through the oad with minimal resistance.The oad was found to operate at all three speeds with no abnormalities or unusual noises observed.At the conclusion of the device analysis investigation, the reported event could not be conclusively confirmed through analysis.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.The material inspection report for this guide wire 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.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; saint paul MN 55112
• MDR Report Key: 8197119
• Report Number: 3004742232-2018-00377
• Device Sequence Number: 19398469
• Product Code: MCW
• UDI-Device Identifier: 10852528005015
• UDI-Public: (01)10852528005015(17)211130(10)246776
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• 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): 01/11/2019

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: 11/30/2021
• Device Model Number: DBE-150
• Device Catalogue Number: 70056-01
• Device Lot Number: 246776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1