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

Model Number VPR-GW-14

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

Csi was made aware of the event on 21 january 2020.However, there was no information to suggest a csi device contributed to the event until 10 february 2020.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.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.The diamondback peripheral orbital atherectomy system instructions for use states that perforation and slow flow are possible adverse events which can occur with use of the diamondback peripheral orbital atherectomy system.Csi id# (b)(4).

Event Description

A diamondback peripheral orbital atherectomy device (oad) was used to treat a calcified lesion in the distal anterior tibial (at) and dorsalis pedis (dp) artery.The diameter of the at was 2.5mm, and the diameter of the dp was 2.0mm.The lesion was accessed with two non-csi guide wires, and then an exchange was done for the viperwire guide wire.After orbital atherectomy treatment, the vessel area where the lesion was located appeared open, however, distal to the treatment area, there was no flow, and there appeared to be a perforation.The opinion of the physician was that wiring of the vessel contributed to the perforation and no flow, but it is unclear which wire contributed to or caused the reported issues.The patient remained in the hospital after the procedure for pre-existing issues unrelated to the reported events.

Event Description

No other treatment for perforation or no flow was reported.A below-the-knee amputation was performed on (b)(6) 2020, and was released from the hospital on (b)(6) 2020.It was noted that the original atherectomy procedure (on (b)(6) 2020) had been the last effort to avoid amputation for the patient.

Manufacturer Narrative

H6 patient code: 3191 suggested code: below-the-knee amputation.Csi id# (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9723022
• MDR Text Key: 192487458
• Report Number: 3004742232-2020-00039
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)210131(10)258572
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 258572
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 63 YR
• Patient Weight: 65