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	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	10/30/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that a diamondback 360 precision coronary orbital atherectomy device (oad) performed 10 low-speed treatments in the severely calcified, diffuse, mildly tortuous right coronary artery (rca).Following atherectomy, a 2.5 x 15mm sapphire nc24 ptca balloon was used to perform balloon angioplasty.Angiographic images taken post balloon angioplasty showed perforation.Two covered stents were deployed.The patient experienced hypotension and was intubated.The patient was unstable and remained in the hospital.Per the opinion of the physician the oad likely contributed to the perforation.They suspect the perforation likely occurred during balloon angioplasty but exact cause could not be confirmed.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The sapphire balloon referenced in b5 is filed under separate medwatch report number.
Additional Manufacturer Narrative
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 effects of perforation of vessels, low blood pressure, hospitalization, unexpected medical intervention and death appear to be related to operational context.In this case it is possible that the reported patient effects of perforation of vessels, low blood pressure, hospitalization, unexpected medical intervention 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: b2, b5, g3, g6, h1, h2, h6 [(code 1802 added), (codes 4118, 3233, and 11 no longer apply)].
Event or Problem Description
It was reported that a diamondback 360 precision coronary orbital atherectomy device (oad) performed 10 low-speed treatments in the severely calcified, diffuse, mildly tortuous right coronary artery (rca).Following atherectomy, a 2.5 x 15mm sapphire nc24 ptca balloon was used to perform balloon angioplasty.Angiographic images taken post balloon angioplasty showed perforation.Two covered stents were deployed.The patient experienced hypotension and was intubated.The patient was unstable and remained in the hospital.Per the opinion of the physician the oad likely contributed to the perforation.They suspect the perforation likely occurred during balloon angioplasty but exact cause could not be confirmed.Subsequent to the previously filed report, additional information was received: the patient later expired.The date of death will be estimated as (b)(6) 2025.

• 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: 23610012
• Report Number: 3004742232-2025-00352
• Device Sequence Number: 15754035
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)270831(10)580430-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/26/2026

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: 580430-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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: Hospitalization; Death; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female