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 Enzyme Elevation (1838); Myocardial Infarction (1969); Vascular Dissection (3160)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
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 myocardial infarction, cardiac enzyme elevation, vascular dissection and serious injury appear to be related to operational context.In this case it is likely that the reported myocardial infarction, cardiac enzyme elevation, vascular dissection and serious injury are a result of the patient¿s disease severity combined with 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.D4: the udi number is not known as the part and lot number were not provided.
Event or Problem Description
Ecl-088-052 - elevated cardiac biomarkers were observed during post-procedure monitoring following treatment with a diamondback coronary orbital atherectomy device.A type a dissection was also noted.The healthcare provider documented that the elevation in biomarker levels and type a dissection were not life-threatening, did not result in permanent impairment of a body function or permanent damage to a body structure, did not lead to a serious deterioration in the health of the subject, and did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The event did not result in additional or extended hospitalization.Additional information received indicated the clinical event committee reviewed images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed to a myocardial infarction.
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 myocardial infarction, cardiac enzyme elevation, vascular dissection and serious injury appear to be related to operational context.In this case it is likely that the reported myocardial infarction, cardiac enzyme elevation, vascular dissection and serious injury are a result of the patient¿s disease severity combined with 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.D4: updated device information.
Event or Problem Description
(b)(4) - elevated cardiac biomarkers were observed during post-procedure monitoring following treatment with a diamondback coronary orbital atherectomy device.A type a dissection was also noted.The healthcare provider documented that the elevation in biomarker levels and type a dissection were not life-threatening, did not result in permanent impairment of a body function or permanent damage to a body structure, did not lead to a serious deterioration in the health of the subject, and did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The event did not result in additional or extended hospitalization.Additional information received indicated the clinical event committee reviewed images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed to a myocardial infarction.
Event or Problem Description
(b)(6) - elevated cardiac biomarkers were observed during post-procedure monitoring following treatment with a diamondback coronary orbital atherectomy device.A type a dissection was also noted.The healthcare provider documented that the elevation in biomarker levels and type a dissection were not life-threatening, did not result in permanent impairment of a body function or permanent damage to a body structure, did not lead to a serious deterioration in the health of the subject, and did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The event did not result in additional or extended hospitalization.Additional information received indicated the clinical event committee reviewed images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed to a myocardial infarction.
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 myocardial infarction, cardiac enzyme elevation, vascular dissection and serious injury appear to be related to operational context.In this case it is likely that the reported myocardial infarction, cardiac enzyme elevation, vascular dissection and serious injury are a result of the patient¿s disease severity combined with 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.D4: catalog number updated.

• 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: 21950143
• Report Number: 3004742232-2025-00117
• Device Sequence Number: 8800456
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211130(10)298551
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/10/2025

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: 11/30/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 298551
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/29/2025; 07/08/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2019
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White