MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number	DBEC-125
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported a diamondback 360 coronary orbital atherectomy device (oad) was being used to treat severely calcified, severely angulated left main (lm) into the left circumflex (cx).A workhorse wire was placed down the cx and exchanged for a viperwire guide wire using an unspecified microcatheter.Two low speed treatments were performed.During the third treatment, the oad crown was moving retrograde and became trapped in the mid cx.The physician attempted to use glideassist mode to free the oad, however, this was unsuccessful.The oad was then started on low speed, but this was unsuccessful and the oad stalled.Upon further angiographic inspection, it was noted the oad driveshaft had fractured at the proximal edge of the oad crown.A second wire was placed down the vessel, and an unspecified 1.25 balloon was inflated several times to entrap the fractured component.The viperwire was pulled back to the tip of the oad and the guide catheter was advanced to the ostium of the circumflex.All components were removed and nothing remained in-vivo.There were no patient complications as a result of the event.The patient was in stable condition.It was indicated the fracture most likely occurred due to angulation of the osital/proximal cx and severity of the calcium.The issue with the device getting stuck was due to the device damage.The vessel diameter was 3.5mm.
Additional Manufacturer Narrative
A visual inspection, functional testing, and detailed analysis were performed on the returned device.The reported driveshaft fracture and unexpected shutdown were confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported driveshaft fracture and unexpected shutdown appears to be related to circumstances of the procedure.The oad was returned with a driveshaft fracture at the proximal edge of the crown that shows evidence of fatigue failure.Detailed analysis shows that the device experienced numerous stall and bog (speed drops) events during the procedure.Fatigue failure is an indication that the fracture occurred while spinning in an elevated stress environment.This is consistent with reported details which state that oad was being used to treat severely calcified, severely angulated left main into the left circumflex.It is possible that the stall events in the data log are related to the driveshaft fracture and stuck device.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Updated: h6 (codes 4755, 4118, 3233, and 11 no longer apply).
Event or Problem Description
It was reported a diamondback 360 coronary orbital atherectomy device (oad) was being used to treat severely calcified, severely angulated left main (lm) into the left circumflex (cx).A workhorse wire was placed down the cx and exchanged for a viperwire guide wire using an unspecified microcatheter.Two low speed treatments were performed.During the third treatment, the oad crown was moving retrograde and became trapped in the mid cx.The physician attempted to use glideassist mode to free the oad, however, this was unsuccessful.The oad was then started on low speed, but this was unsuccessful and the oad stalled.Upon further angiographic inspection, it was noted the oad driveshaft had fractured at the proximal edge of the oad crown.A second wire was placed down the vessel, and an unspecified 1.25 balloon was inflated several times to entrap the fractured component.The viperwire was pulled back to the tip of the oad and the guide catheter was advanced to the ostium of the circumflex.All components were removed and nothing remained in-vivo.There were no patient complications as a result of the event.The patient was in stable condition.It was indicated the fracture most likely occurred due to angulation of the osital/proximal cx and severity of the calcium.The issue with the device getting stuck was due to the device damage.The vessel diameter was 3.5 mm.

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24626698
• Report Number: 3004742232-2026-00054
• Device Sequence Number: 13028652
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)271130(10)590576-1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 590576-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown