MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number GWC-12325LG-FLP

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

The guide wire was returned for analysis.The guide wire was fractured at the proximal spring tip.Scanning electron microscopy (sem) was performed on the fractured proximal spring tip coil and identified evidence of rotational damage.This evidence suggests the spinning oad driveshaft contacted the guide wire spring tip, resulting in the guide wire fracture.The root cause of the fracture is considered use not consistent with the instructions for use (ifu).The ifu cautions to maintain at least 5 mm between the proximal end of the viperwire guide wire spring tip and the oad drive shaft tip to prevent contact of the drive shaft tip with the guide wire spring tip.Further advance the viperwire guide wire, as necessary, to maintain the 5 mm minimum distance.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.Csi id: (b)(4).

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was used to treat a heavily calcified left anterior descending artery (lad).Following atherectomy treatment, when the oad and viperwire advance guide wire were removed, the viperwire spring tip was observed fractured.A snare was used to successfully retrieve the component.The patient was stable.The physician was unsure when the fracture occurred as there were no issues experienced during the procedure.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• 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: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19153878
• MDR Text Key: 340802561
• Report Number: 3004742232-2024-00165
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 6741718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male