MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(4).
Event or Problem Description
The diamondback coronary orbital atherectomy device (oad) was selected for treatment of the proximal left anterior descending artery.Imaging revealed a vessel perforation following the third orbital atherectomy treatment.The device and guide wire were removed from the patient.Chest compressions were begun.Regaining access to the vessel was complicated by single access through an impella sheath; an alternative access site was created.Balloon tamponade and stent placement were performed but were unsuccessful in resolving the perforation.Efforts to revive the patient were discontinued since the functionality of the heart was deemed unrecoverable.The patient expired.In the opinion of the physician, the high-risk nature of the procedure and the patient's age contributed to the patient death.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 12210182
• Report Number: 3004742232-2021-00267
• Device Sequence Number: 11714118
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230331(10)372914-1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: 03/31/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 372914-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 45