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

Model Number	GWC-12325LG-FT
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135); Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	04/02/2026
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 oad mentioned in b5 is filed under a separate medwatch report.
Event or Problem Description
It was reported a diamondback 360 coronary orbital atherectomy device (oad) was being used to treat a heavily calcified, heavily tortuous, 99% stenosed distal left main (lm)/ostial left circumflex (cx).The patient was given heparin prior to orbital atherectomy, and an impella cp was placed in the patient's right femoral artery.A single access 7fr sheath and guide system was utilized.A non-abbott interventional wire, along with a non-abbott microcatheter, were used to get across the lesion initially.The viperwire guide wire was able to be exchanged in.There were no apparent issues during preparation of the oad.The oad was successfully loaded onto the viperwire, and advanced just proximal to the lesion.A low-speed treatment was performed for five seconds, as the guide catheter was pushing out and there was difficulty remaining engaged.It was determined at this time that the physician was to use glideassist mode to get closer to the lesion and help seat the guide catheter better.Glideasisst mode was used to get the oad next to the lesion better.During this time, the brake lever was not engaged, as they were moving the entire oad at the time.The brake lever was locked prior to initiating the second treatment.During the start of the second treatment, it sounded as though the oad was getting up to low speed but then made an abrupt stop.Upon checking fluoroscopy, it appeared the oad driveshaft fractured just proximal to where the oad crown is.During this time, the was removed from the patient.The patient remained hemodynamically stable at the time and was on the impella cp pump.The oad was removed and it was noted the wire was no longer where the oad came out of the control valve.Another x-ray was taken and it was noted the distal tip and oad crown along with the viperwire at the oad crown remained in-vivo.At this time, the patient became hemodynamically stable.The pressure on the impella was decreased, and the patient was in cardiac arrest.Cardiopulmonary resuscitation (cpr) was administered at this time.The patient was found to have both a dissection into the cx as well as a perforation at the distal left main.Balloon tamponade was attempted to control the perforation, along with pericardiocentesis to remove the blood from the pericardium.The patient had a rv impella placed during this time, as well as bi-impella support.Balloon tamponade was continued, pulling blood from the pericardium, as well as cpr.A surgeon was called and the patient was cannulated for ecmo and transferred to a higher-level facility for emergency coronary artery bypass graft (cabg).Cabg was performed to remove the fractured components and the arteries were bypassed.The patient's chest remained opened and was planned to be closed a few days after the cabg procedure.However, it was indicated the patient expired.In the physician's opinion, it was not clear how the oad and viperwire fractured.It was suggested the viperwire could have become buckled up against the calcific nodules when the oad was in glideassist mode for advancement with the brake lever up.It was also suggested the viperwire could have become entrapped in the oad crown, which at that point the fractures occurred, however, it was unable to be conclusively determined what led to the fractures.It was estimated 130 millimeters of the viperwire was left in-vivo, and an estimated 12 millimeters of the oad driveshaft remained in-vivo.Due to the vessel dissection and perforation, balloon tamponade was prioritized, and the retained fragments were left in-vivo until cabg.It was indicated the orbital atherectomy treatments were performed proximal to distal.In the physician's opinion, the oad caused the perforation.In the physician's opinion, the viperwire contributed to the dissection when it became entrapped in the oad crown.Date of death is an estimate.
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 material separation, difficult to remove, cardiac arrest, death, foreign body in patient, perforation of vessels, surgical intervention, unexpected medical intervention and vascular dissection appears to be related to operational context.In this case, it is possible that the reported material separation, difficult to remove, cardiac arrest, death, foreign body in patient, perforation of vessels, surgical intervention, unexpected medical intervention and vascular dissection were due to patient disease state and/or use techniques employed; however, since the device was not returned this cannot 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.Correction: b1, h1.Updated: h6 (codes 4118, 3233, and 11 no longer apply), h10 (oad report).
Event or Problem Description
It was reported a diamondback 360 coronary orbital atherectomy device (oad) was being used to treat a heavily calcified, heavily tortuous, 99% stenosed distal left main (lm)/ostial left circumflex (cx).The patient was given heparin prior to orbital atherectomy, and an impella cp was placed in the patient's right femoral artery.A single access 7fr sheath and guide system was utilized.A non-abbott interventional wire, along with a non-abbott microcatheter, were used to get across the lesion initially.The viperwire guide wire was able to be exchanged in.There were no apparent issues during preparation of the oad.The oad was successfully loaded onto the viperwire, and advanced just proximal to the lesion.A low-speed treatment was performed for five seconds, as the guide catheter was pushing out and there was difficulty remaining engaged.It was determined at this time that the physician was to use glideassist mode to get closer to the lesion and help seat the guide catheter better.Glideasisst mode was used to get the oad next to the lesion better.During this time, the brake lever was not engaged, as they were moving the entire oad at the time.The brake lever was locked prior to initiating the second treatment.During the start of the second treatment, it sounded as though the oad was getting up to low speed but then made an abrupt stop.Upon checking fluoroscopy, it appeared the oad driveshaft fractured just proximal to where the oad crown is.During this time, the was removed from the patient.The patient remained hemodynamically stable at the time and was on the impella cp pump.The oad was removed and it was noted the wire was no longer where the oad came out of the control valve.Another x-ray was taken and it was noted the distal tip and oad crown along with the viperwire at the oad crown remained in-vivo.At this time, the patient became hemodynamically stable.The pressure on the impella was decreased, and the patient was in cardiac arrest.Cardiopulmonary resuscitation (cpr) was administered at this time.The patient was found to have both a dissection into the cx as well as a perforation at the distal left main.Balloon tamponade was attempted to control the perforation, along with pericardiocentesis to remove the blood from the pericardium.The patient had a rv impella placed during this time, as well as bi-impella support.Balloon tamponade was continued, pulling blood from the pericardium, as well as cpr.A surgeon was called and the patient was cannulated for ecmo and transferred to a higher-level facility for emergency coronary artery bypass graft (cabg).Cabg was performed to remove the fractured components and the arteries were bypassed.The patient's chest remained opened and was planned to be closed a few days after the cabg procedure.However, it was indicated the patient expired.In the physician's opinion, it was not clear how the oad and viperwire fractured.It was suggested the viperwire could have become buckled up against the calcific nodules when the oad was in glideassist mode for advancement with the brake lever up.It was also suggested the viperwire could have become entrapped in the oad crown, which at that point the fractures occurred, however, it was unable to be conclusively determined what led to the fractures.It was estimated 130 millimeters of the viperwire was left in-vivo, and an estimated 12 millimeters of the oad driveshaft remained in-vivo.Due to the vessel dissection and perforation, balloon tamponade was prioritized, and the retained fragments were left in-vivo until cabg.It was indicated the orbital atherectomy treatments were performed proximal to distal.In the physician's opinion, the oad caused the perforation.In the physician's opinion, the viperwire contributed to the dissection when it became entrapped in the oad crown.Date of death is an estimate.

• 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; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24984313
• Report Number: 3004742232-2026-00101
• Device Sequence Number: 10468434
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)271130(10)592375-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/01/2026

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 Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 592375-1
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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: Unknown