MAUDE Adverse Event Report: Cardiovascular Systems Incorporated Diamondback Coronary; Catheter, Coronary, Atherectomy

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	06/03/2026
Type of Reportable Event	Death
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 that during procedure to treat 90% stenosed heavily calcified mid proximal circumflex artery with mild tortuosity using a diamondback 360 coronary orbital atherectomy device (oad).Perforation occurred in the left main (lm) to ostial circumflex during atherectomy.The patient experienced cardiac arrest and expired.It was noted that the physician used correct procedure technique and there was no alleged malfunction of the device.
Event or Problem Description
It was reported that during procedure to treat 90% stenosed heavily calcified mid proximal circumflex artery with mild tortuosity using a diamondback 360 coronary orbital atherectomy device (oad).Perforation occurred in the left main (lm) to ostial circumflex during atherectomy.The patient experienced cardiac arrest and expired.It was noted that the physician used correct procedure technique and there was no alleged malfunction of the device.Additional information was received and in the physician's opinion, the primary cause of death was perforation and secondary was that it was unable to cover the perforation.The physician believed the oad pulled a dissection and caused perforation.The patient was coded for about 45-60 min before pronouncing death.The patient did not recover after cardiac pulmonary resuscitation.No treatment was administered to resolve perforation as the patient expired.
Additional Manufacturer Narrative
H6 - health effect - clinical code 3160 and health effect - impact code 4641 were added.The device was not returned for analysis.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 information received, the investigation determined that the reported patient perforation of vessels, cardiac arrest, vascular dissection and death appears to be related to operational context.In this case it is possible that the reported patient perforation of vessels, cardiac arrest, vascular dissection and death are a result of the patient¿s disease severity and/or use techniques employed; however, since the device was not returned this could not be confirmed.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 fields: b5, g3, g6, h2, h6 (health effect - clinical code, health effect - impact code, type of investigation, investigation findings, investigation conclusions) and h11.

• 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 ; +1(651)756-2718
• MDR Report Key: 25616643
• Report Number: 3004742232-2026-00152
• Device Sequence Number: 9102074
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)280131(10)597846-1
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/16/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 597846-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2026
• 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: Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 199 LB
• Patient Race: White