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

Model Number	DBP-125SOLID145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
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
A diamondback peripheral orbital atherectomy device (oad) was selected for treatment of a chronic total occlusion in the anterior tibial artery (at).There was pre-existing no flow to the foot due to the occlusion.The lesion was pre-dilated with a balloon.During treatment, the device stopped spinning: the oad was stuck on the wire and was stuck in the vessel.Alternative access was gained in the dorsalis pedis artery, and the crown was loosened via that approach.A balloon was inflated near the crown, and the device was removed.During removal, the oad crown became stuck again near the at bend, and the crown and distal driveshaft fractured and were removed.The event caused a delay that was greater than 30 minutes.
Additional Manufacturer Narrative
Failure analysis conclusion: a partial oad was returned to csi for analysis.The distal driveshaft and crown were not returned.Scanning electron microscopy was performed and identified that the missing section had been destructively cut from the driveshaft.Multiple locations of the driveshaft were deformed and damaged, and the saline sheath was separated at one location.During functional testing, the device spun as intended.It is hypothesized that the damage to the driveshaft and saline sheath separation is the result of device removal attempts.However, the exact cause was not determined.At the conclusion of the failure analysis investigation the reported stopped-spinning and procedural delay events could not be confirmed.The reported stuck-in-vessel and stuck-on wire events could not be confirmed as the driveshaft crown section and the guide wire were not returned for analysis.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 hwy 8 nw; st. paul MN 55112
• MDR Report Key: 9473500
• Report Number: 3004742232-2019-00333
• Device Sequence Number: 2751354
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)210731(10)281341
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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): 01/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 281341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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