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

Device Problems Unintended System Motion (1430); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

The target treatment area was the left circumflex artery (lcx).The vessel was 3.5mm, 90% stenosed, with moderate tortuosity and heavily calcified.The lcx was checked with intravascular ultrasound (ivus), and then the viperwire advance guidewire and the diamondback 360 coronary orbital atherectomy device (oad) were advanced.While advancing the oad, the crown was observed to have jumped and contacted the viperwire spring tip.The oad and viperwire were immediately separated but the viperwire spring tip had been fractured.The oad and viperwire were removed.Attempts to remove the fractured component with non-csi devices were unsuccessful.The fractured component was left in patient.

Manufacturer Narrative

The oad was not returned, only the viperwire was returned for analysis.The results of the investigation are inconclusive for the oad since the reported device was not returned for analysis.Based on the information received, the cause of the reported crown jumping could not be conclusively determined.The guide wire was returned with a fracture at the spring tip bond.Scanning electron microscopy (sem) was performed on the core wire fracture face and identified evidence of ductile torsion.Spinning contact of the driveshaft tip bushing and the spring tip can lead to ductile torsion fracture.This damage is consistent with the reported event details.The instructions for use (ifu) cautions to use fluoroscopy to monitor movement of the radiopaque oad shaft tip in relation to the radiopaque viperwire spring tip.Maintain a minimum distance of 5mm spacing between the distal end of the oad driveshaft tip and the proximal end of the viperwire spring tip.The root cause of the guide wire fracture is use not consistent with the ifu.The device history record for the reported oad could not be reviewed as the lot number was not provided.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 and the device met material, assembly, and quality control requirements prior to distribution.Additionally, a review of the complaint history identified no similar incidents from this lot.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18502788
• MDR Text Key: 332777606
• Report Number: 3004742232-2024-00078
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GWC-12325LG-FT (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male