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

Model Number	DBEC-125
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis.The driveshaft was fractured at the distal edge of the crown.Scanning electron microscopy identified fatigue striations at the site of the driveshaft fracture.Driveshaft flexing at the weld location can initiate fatigue.It is hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape, although the exact root cause of the reported event is undetermined.At the conclusion of the device analysis, the reported event of a driveshaft fracture was confirmed.The coronary oas instructions for use states, "never force the crown if any resistance is felt within the vessel as vessel perforation may occur.If resistance is felt, retract the crown, while monitoring the cause of the resistance, and immediately stop treatment.Use fluoroscopy to analyze the situation and to monitor the cause of the resistance." 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.(b)(4).
Event or Problem Description
A diamondback coronary orbital atherectomy device (oad) was selected for treatment of a extremely calcified lesion in the left anterior descending coronary artery (lad).The lad was tortuous and varied between 2.5 and 3.5mm.Four proximal to distal treatments were performed, but the oad was unable to pass through the lesion due to the calcium and tortuosity of the vessel.During the final treatment, the distal tip of the oad became stuck in the lesion, and the driveshaft fractured at the distal edge of the crown.The oad fragment was retrieved on the guide wire.The procedure was completed with balloon angioplasty and stent placement.The patient was stable following the procedure.

• 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: 12374686
• Report Number: 3004742232-2021-00304
• Device Sequence Number: 11965721
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)230131(10)364315-1
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 364315-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 56