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); Vascular Dissection (3160)
Date of Event	12/19/2019
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, vascular dissection, obstruction, and serious injury appear to be related to operational context.In this case it is likely that the reported myocardial infarction, vascular dissection, obstruction, 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.H10: additional information was received related to previously submitted mdr.Cardiovascular systems incorporated has transitioned to a new complaint handling system and no longer has access to submit follow-up mdrs using esubmitter/webtrader.This mdr is being filed from our new system using the as2 gateway with reference to the previously reported manufacturer report number in h10.
Event or Problem Description
(b)(4) - following atherectomy using a diamondback 360 coronary orbital atherectomy device (oad), angiographic imaging observed a type c dissection in the proximal left anterior descending artery (lad).The clinical event committee reviewed the images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed.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 periprocedural myocardial infarction with side branch occlusion observed.
Event or Problem Description
Ecl-088-045 - following atherectomy using a diamondback 360 coronary orbital atherectomy device (oad), angiographic imaging observed a type c dissection in the proximal left anterior descending artery (lad).The clinical event committee reviewed the images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed.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 periprocedural myocardial infarction with side branch occlusion observed.
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, vascular dissection, obstruction, and serious injury appear to be related to operational context.In this case it is likely that the reported myocardial infarction, vascular dissection, obstruction, 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.B4: updated device information.
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, vascular dissection, obstruction, and serious injury appear to be related to operational context.In this case it is likely that the reported myocardial infarction, vascular dissection, obstruction, 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.
Event or Problem Description
Following atherectomy using a diamondback 360 coronary orbital atherectomy device (oad), angiographic imaging observed a type c dissection in the proximal left anterior descending artery (lad).The clinical event committee reviewed the images and concluded that the use of the diamondback 360 coronary orbital atherectomy device may have contributed.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 periprocedural myocardial infarction with side branch occlusion observed.

• 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: 21950109
• Report Number: 3004742232-2025-00116
• Device Sequence Number: 12941700
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211130(10)298276
• 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: 298276
• 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: 12/18/2019
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White