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

Model Number DBEC-125

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 03/18/2024

Event Type  Injury  

Manufacturer Narrative

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 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.Csi id: (b)(4).

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was used for treatment in a 3.5mm, 80% stenosed, heavily calcified with moderate tortuosity right coronary artery (rca).The oad was spun for 10-12 treatments on slow speed in the proximal rca with no issue.Glideassist was activated and an attempt was made to advance the oad further distally to treat a second tight and tortuous stenosis, but the oad stopped spinning and the motor turned off, but the led lights remained illuminated.The saline pump functioned as intended and the power connections were checked and secured.After a few seconds, the on/off button on the oad was pressed and the oad activated but quickly stopped spinning again and became stuck in the vessel.A non-csi/abbott balloon was advanced and inflated and successfully freed the oad crown.The oad was removed and ex vivo, a small fracture distal to the crown was observed.It was the physician's opinion the fracture occurred during pulling attempts to remove the stuck oad, prior to balloon intervention.The oad was removed intact, no components were left in vivo.Angioplasty and stent placement were performed to complete the procedure.The patient was stable.The physician's opinion was the patient's anatomy contributed to the oad not advancing.

• 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 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: 19078298
• MDR Text Key: 339801420
• Report Number: 3004742232-2024-00139
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491417
• UDI-Public: (01)10850000491417(17)250531(10)491373-1
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

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: 7-10060-03
• Device Lot Number: 491373-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2023
• 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