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

Model Number DBEC-125

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

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 12/29/2023

Event Type  Injury  

Event Description

During treatment of a highly calcified 95% stenosed lesion in the right coronary artery (rca), the diamondback 360 coronary orbital atherectomy device was spun twice on low speed.The crown jumped forward and hit the weld joint.The viperwire advance guide wire tip sheared off and the oad was just swinging around in the vessel.When an attempt was made to remove the oad, it was noted that the oad was stuck to the wire.After removal of the oad, it was noted that the guide wire tip was no longer attached to body of the wire and perforation was observed.The physician was able to rewire the rca and place a stent across the lesion.Imaging results showed that the guide wire tip remained in the vessel.The physician opted to leave the wire tip in the vessel as it had migrated to apex of the heart and was suspected to cause more damage upon removal.The wire tip was left in the rca.Perforation was covered with a stent and the patient was stable.A surgeon on call was notified and the patient was sent to the intensive care unit for monitoring.St elevations and a drop in blood pressure was noted during the intervention.

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that perforation is a potential adverse event that may occur and/or require intervention with use of the system.H6: 3211 is related to the guide wire and 213 is related to the oad.The oad and guide wire were returned for analysis.The perforation was unable to be confirmed through analysis.The guide wire fracture was observed near the proximal spring tip.The spring tip section was not returned for analysis.Scanning electron microscopic (sem) analysis identified evidence of ductile torsion on the core wire fracture face and radiopaque particles on the oad tip bushing.This evidence suggests the spinning driveshaft made contact with the spring tip, leading to the fracture.The root cause of the event was determined to be use not consistent with the diamondback 360 coronary orbital atherectomy device instructions for use (ifu).The ifu states "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".Review of the device data log determined one stall event occurred during the procedure.It was unable to be determined whether the stall contributed to the event.There was no damage or abnormalities identified with the driveshaft or handle assembly that would have contributed to the reported complaint.When tested the oad functioned as intended with no crown jumping observed.The device history record for this oad 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 material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.Csi id: (b)(4).

Manufacturer Narrative

Updated fields: b1, b4, g3, g6, h2, h5, h6 csi id: (b)(6).

• 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 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old highway 8 nw; st. paul, MN 55112
• MDR Report Key: 18588715
• MDR Text Key: 333854941
• Report Number: 3004742232-2024-00093
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250831(10)503792-1
• 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,Followup
• Report Date: 01/26/2024

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: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 503792-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 72010-01/GWC-12325LG-FLPUNKNOWN LOT NUMBER
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: White