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

Model Number GWC-12325LG-FLP

Device Problem Material Separation (1562)

Patient Problems Vascular System (Circulation), Impaired (2572); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient demographic data are based on averages and majority representation within the study.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 the reported guide wire was unable to be reviewed, as the lot number was not provided.The instructions for use for the coronary orbital atherectomy system state that use of the system is contraindicated when the target lesion is within a bypass graft or stent.Csi id: (b)(4).

Event Description

Yasumura et al 2020 - a literature article was written which indicated that a viperwire guide wire fracture occurred during treatment of in-stent restenosis (isr).The cause of the wire fracture in a single case in the present series is unknown.In this case, oa was performed with low speed for the isr lesion after changing to the viperwire.There was no resistance throughout the forty second debulking procedure, but after the procedure angiography revealed slow flow and distal guide wire fragment fracture.After balloon angioplasty to the lesion, timi-3 flow and adequate lumen enlargement were obtained.The fractured wire fragment could not be retrieved by a snare, and it remained in the distal coronary artery.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn, mn
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, mn ; 2591600
• MDR Report Key: 10100809
• MDR Text Key: 193405364
• Report Number: 3004742232-2020-00149
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2020

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
• Device Operator: Health Professional
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR