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 Code	Obstruction/Occlusion (2422)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a de novo, heavily calcified, moderately tortuous left anterior descending (lad) artery lesion with 98% stenosis.The vessel was ballooned and a 1.25mm diamondback coronary orbital atherectomy device was used.Both a 3x28 mm xience skypoint drug-eluting stent (des) and a 3.25x18 mm xience skypoint des were implanted without issue.A non-abbott guide wire caused the lad to dissect and shut down flow distal to the stent edge.The circumflex (cx) artery also shut down.Angios performed before and after the procedure confirmed the circumflex was no longer open and likely clotted with persistent no flow.It was noted that the non-abbott wire had lost position.When the wire lost position, the physician was able to get the guide back in left main artery and took a picture that confirmed dissection.The dissection was distal to the stent and spiraled down the lad.Dissection and shut down of cx were not treated.The physician attempted to use a balloon pump and performed chest compressions shocking the patient.The patient later died due to dissection.The physician was not sure about what caused the cx to shut down but believed the non-abbott wire dissected the distal lad.In the opinion of the physician, no reflow was the primary cause of death and the oad did not cause/contribute to patient's death.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• 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 ; +1(651)756-2718
• MDR Report Key: 50409067
• Report Number: 3004742232-2026-00202
• Device Sequence Number: 18750092
• Product Code: MCX
• UDI-Device Identifier: 10850026568698
• 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): 09/24/2026

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 Model Number: DBEC-125
• Device Catalogue Number: 7-10098-01
• Device Lot Number: 576760-1
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: Other
• Patient Sex: Unknown