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

Model Number VPR-GW-FT14

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. Csi id: (b)(4).

Event Description

Difficulty was encountered during advancement of the viperwire into the distal anterior tibial artery. The vessel exhibited 100% stenosis, and the lesion of interest was type b. Seven treatments were completed with the orbital atherectomy device (oad). During the last treatment, the oad became stuck but was eventually retracted. Difficulty was encountered during removal of the viperwire since it was stuck in a calcified region of the vessel. During attempts to remove the wire, it fractured. The intact portion of the wire was removed, the vessel was re-wired, and the procedure was continued. The fragment was left in vivo, and a stent was used to fix the fragment to the vessel wall. The procedure concluded with good results and the patient was stable.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 8195960
• MDR Text Key: 131391078
• Report Number: 3004742232-2018-00380
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2020
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 234376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/26/2018 Patient Sequence Number: 1