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

Model Number	GWC-12325LG-FT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Ischemia (1942); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure to treat 95% stenosed severely calcified tight mid right coronary artery lesions with mild tortuosity, a non-abbott 6f guide was used to primarily wire the vessel with viperwire advance coronary guidewire.The vessel was 2.75-3.0mm in diameter and 50 mm in length.The vessel was prepped and a diamondback 360 precision coronary orbital atherectomy device (oad) was advanced just proximal to the lesion.Within the specific area/lesion that was being treated, there were two tighter spots.Two treatments were performed without any jump for approximately 27 seconds all the way to the end of the planned treatment area.The treatment was paused 1:1 and then treatment was performed for approximately 27 seconds.The treatment was rested 1:1 and repeated thrice.There were puffs taken between runs to make sure vessel remained open and there were no issues.Occasional puffs of contrast taken between treatments.At the end of the last treatment, the patient's heart rate slowed.It was noted that the patient already had a slow heart rate, therefore temporary pacer was placed at the beginning and pacer setting were established at the beginning.The pacer kicked in after each treatment.The oad was removed without issues and a small dissection (type c) with small ischemia/electrocardiogram changes were noted.Dissection at the distal end of the lesion caused slow flow.The patient was treated with balloons and stents.The patient was stable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 ischemia, vascular dissection, occlusion, ekg changes and unexpected medical intervention appears to be related to operational context.In this case it is possible that the reported patient ischemia, vascular dissection, occlusion, ekg changes and unexpected medical intervention 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 fields: g3, g6, h2, h6 (correction: health effect- clinical code), h6 (type of investigation, investigation findings, investigation conclusions) and h11.
Event or Problem Description
It was reported that during procedure to treat 95% stenosed severely calcified tight mid right coronary artery lesions with mild tortuosity, a non-abbott 6f guide was used to primarily wire the vessel with viperwire advance coronary guidewire.The vessel was 2.75-3.0mm in diameter and 50 mm in length.The vessel was prepped and a diamondback 360 precision coronary orbital atherectomy device (oad) was advanced just proximal to the lesion.Within the specific area/lesion that was being treated, there were two tighter spots.Two treatments were performed without any jump for approximately 27 seconds all the way to the end of the planned treatment area.The treatment was paused 1:1 and then treatment was performed for approximately 27 seconds.The treatment was rested 1:1 and repeated thrice.There were puffs taken between runs to make sure vessel remained open and there were no issues.Occasional puffs of contrast taken between treatments.At the end of the last treatment, the patient's heart rate slowed.It was noted that the patient already had a slow heart rate, therefore temporary pacer was placed at the beginning and pacer setting were established at the beginning.The pacer kicked in after each treatment.The oad was removed without issues and a small dissection (type c) with small ischemia/electrocardiogram changes were noted.Dissection at the distal end of the lesion caused slow flow.The patient was treated with balloons and stents.The patient was stable.

• 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: 24700017
• Report Number: 3004742232-2026-00063
• Device Sequence Number: 21370214
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)260831(10)548682-1
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/24/2026

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: 08/31/2026
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 548682-1
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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: Required Intervention
• Patient Sex: Unknown