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	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	05/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that atherectomy was performed to treat 80% stenosed moderately calcified, mildly tortuous mid left anterior descending (lad) artery.After multiple guide selections were made, a non- abbott wire was advanced past the lesion.A microcatheter was advanced over the guidewire and exchanged for the viperwire coronary flex tip guidewire.The microcatheter was removed and a diamondback 360 coronary orbital atherectomy device (oad) was advanced over the viperwire coronary guidewire.Seven treatments varying between 30 and 32 seconds were performed at low speed.Patient tolerated well and the lesion was treated.The patient¿s pressure began to drop and a quick angiogram was performed discovering a perforation of the mid lad.All atherectomy equipment was removed from the patient and life saving measures were started.After consulting with other interventional cardiologist and as it was unable to get a balloon or a covered stent down the vessel, the patient was transferred to open heart surgery that was successful.In the opinion of the physician, the oad caused patient's hypotension and perforation.The patient's base heart rate was in 70s.The perforation caused by the oad resulted in the patient's emergent surgery.The patient expired the next day after surgery.
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 effects of perforation of vessels, low blood pressure, surgical intervention, unexpected medical intervention and death appear to be related to operational context.In this case it is possible that the reported patient effects of perforation of vessels, low blood pressure, surgical intervention, 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.

• 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: 25487925
• Report Number: 3004742232-2026-00144
• Device Sequence Number: 18754219
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• UDI-Public: (01)10850026568698(17)261130(10)557878-1
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 06/12/2026

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: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 557878-1
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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; Required Intervention
• Patient Sex: Unknown