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

Model Number	DBEC-125
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/15/2021
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
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a lesion in the proximal circumflex artery via femoral access.The oad jumped forward during the first treatment.Imaging showed the vessel was patent.A second treatment was started, and the patient experienced chest pain after seven seconds.Imaging revealed a proximal type d dissection, and the oad was removed.A stent was placed reaching the circumflex artery, however the dissection was not resolved.It was unclear if the dissection extended into the left main artery.Kissing stents were placed from the lad and circumflex into the left main, and the dissection was resolved and the procedure completed.After seeing the stents on imaging, the physician noted the tortuosity of the vessel was more acute than previously thought.The patient remained hemodynamically stable throughout the procedure and was transferred to the intensive care unit.
Additional Manufacturer Narrative
Initial report: b5: was submitted on 10-aug-2021.Csi id# (b)(4).

• 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: 12299903
• Report Number: 3004742232-2021-00281
• Device Sequence Number: 14355494
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230331(10)371189-1
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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?: Yes
• 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: 371189-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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: Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 99