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	Myocardial Infarction (1969); Obstruction/Occlusion (2422)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Ecl-165-032 - it was reported a diamondback 360 coronary orbital atherectomy device (oad) was used to treat a 80% stenosed, severely calcified mid right coronary artery (rca) and a 71% stenosed, severely calcified mid left anterior descending artery (lad).Three low speed treatments were performed on the mid lad.Four low speed treatments were performed and one high speed treatment was performed on the mid rca.There were no device deficiencies noted during the procedure.There were no patient complications related to orbital atherectomy noted during the procedure.The clinical event committee reviewed the images and concluded that the use of the diamondback 360 coronary orbital atherectomy device possibly contributed to a myocardial infarction, as side branch occlusion was observed.
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 used to treat a 80% stenosed, severely calcified mid right coronary artery (rca) and a 71% stenosed, severely calcified mid left anterior descending artery (lad).Three low speed treatments were performed on the mid lad.Four low speed treatments were performed and one high speed treatment was performed on the mid rca.There were no device deficiencies noted during the procedure.There were no patient complications related to orbital atherectomy noted during the procedure.The clinical event committee reviewed the images and concluded that the use of the diamondback 360 coronary orbital atherectomy device possibly contributed to a myocardial infarction, as side branch occlusion was observed.
Additional Manufacturer Narrative
H6: correction to add code 2422.H6: codes 4118, 3233, and 11 no longer apply.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 myocardial infarction, obstruction/occlusion and serious injury appears to be related to operational context.In this case it is likely that the reported patient myocardial infarction, obstruction/occlusion and serious injury are a result of the patient¿s disease severity combined 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.

• 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: 21891355
• Report Number: 3004742232-2025-00100
• Device Sequence Number: 15490478
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)221231(10)358833
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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 Expiration Date: 12/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 358833
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2020
• 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: Other
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White