MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number	GWC-12325LG-FLP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	03/03/2026
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.The orbital atherectomy device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat heavily calcified, non-tortuous, 85% stenosed proximal right coronary artery (rca) with diamondback 360 precision orbital atherectomy device (oad).The lesion was primary wired with viperwire advance coronary guide wire (floppy) through right femoral artery access.From angiogram it appeared the viperwire was in true lumen, sitting in mid to distal rca, straight and not in a branch.No vessel preparation was performed.Several low-speed oad treatments were performed followed by 2 high-speed treatments.After oad removal, angiographic images showed no reflow in the treated rca.The patient became apneic (short of breath) and blood pressure dropped to low (hypotension).Cardiopulmonary resuscitation (cpr) and emergency medications were administered including atropine, but patient did not respond.Echo cardiogram was taken but no perforation was observed.The patient expired after 45 minutes of unsuccessful resuscitation efforts.The physician thinks the patient¿s disease contributed to the event and there was something else going on with patient¿s stability and sickness making the patient unable to tolerate the treatment.In the opinion of the physician, the probable cause of hypotension was persistent no reflow in rca likely caused by dissection of distal rca at distal tip of viperwire, though distal embolization of debris from atherectomy of the proximal vessel is likely to have contributed.No pretreatment of artery led up to the no flow.The patient¿s baseline heart rate (hr) was 70s.Transvenous pacer was in place before starting the percutaneous coronary intervention (pci) but was not used until 30 minutes into the code.There was no sign of bradycardia from the atherectomy itself.In the opinion of the physician, the primary cause of death was cardiac arrest from refractory hypotension during revascularization attempt of severe rca stenosis.There were plenty of secondary contributors, including diffuse coronary artery disease (cad) elsewhere requiring high-risk coronary artery bypass grafting (cabg) and pcis in the recent past, and end-stage renal disease (esrd) on dialysis.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h6, h10.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 dyspnea, cardiac arrest, low blood pressure, occlusion, vascular dissection, medication, unexpected medical intervention, and death appear to be related to operational context.In this case it is possible that the reported dyspnea, cardiac arrest, low blood pressure, occlusion, vascular dissection, medication, 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.
Event or Problem Description
It was reported that the procedure was to treat heavily calcified, non-tortuous, 85% stenosed proximal right coronary artery (rca) with diamondback 360 precision orbital atherectomy device (oad).The lesion was primary wired with viperwire advance coronary guide wire (floppy) through right femoral artery access.From angiogram it appeared the viperwire was in true lumen, sitting in mid to distal rca, straight and not in a branch.No vessel preparation was performed.Several low-speed oad treatments were performed followed by 2 high-speed treatments.After oad removal, angiographic images showed no reflow in the treated rca.The patient became apneic (short of breath) and blood pressure dropped to low (hypotension).Cardiopulmonary resuscitation (cpr) and emergency medications were administered including atropine, but patient did not respond.Echo cardiogram was taken but no perforation was observed.The patient expired after 45 minutes of unsuccessful resuscitation efforts.The physician thinks the patient¿s disease contributed to the event and there was something else going on with patient¿s stability and sickness making the patient unable to tolerate the treatment.In the opinion of the physician, the probable cause of hypotension was persistent no reflow in rca likely caused by dissection of distal rca at distal tip of viperwire, though distal embolization of debris from atherectomy of the proximal vessel is likely to have contributed.No pretreatment of artery led up to the no flow.The patient¿s baseline heart rate (hr) was 70s.Transvenous pacer was in place before starting the percutaneous coronary intervention (pci) but was not used until 30 minutes into the code.There was no sign of bradycardia from the atherectomy itself.In the opinion of the physician, the primary cause of death was cardiac arrest from refractory hypotension during revascularization attempt of severe rca stenosis.There were plenty of secondary contributors, including diffuse coronary artery disease (cad) elsewhere requiring high-risk coronary artery bypass grafting (cabg) and pcis in the recent past, and end-stage renal disease (esrd) on dialysis.

• 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: 24728563
• Report Number: 3004742232-2026-00071
• Device Sequence Number: 9286939
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)260630(10)8689726
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/21/2026

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 Expiration Date: 06/30/2026
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 8689726
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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 Sex: Female