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

Model Number	DBEC-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the device is in progress.A follow-up report will be submitted after the analysis is completed.Csi id: (b)(4).
Event or Problem Description
During treatment in the ostial circumflex artery, which was heavily calcified, the driveshaft of the diamondback 360 coronary orbital atherectomy device fractured on the proximal side of the crown.Several treatments had been performed prior to the fracture.The fragment was snared without difficulty.The patient was well following angioplasty and stent placement; there was no injury.The oa treatment was successful despite the fracture.
Additional Manufacturer Narrative
The oad was returned to csi for analysis.The reported driveshaft fracture was confirmed.Scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.Driveshaft flexing can result in fatigue failure.The exact root cause of the fracture is undetermined.It should be noted that the diamondback 360 coronary orbital atherectomy system instructions for use manual warns, "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 ifu also states, "performing treatment in excessively tortuous or angulated vessels or bifurcations may result in vessel damage or device failure requiring retrieval." 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).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 14538809
• Report Number: 3004742232-2022-00128
• Device Sequence Number: 17321510
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220630(10)329763
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 06/30/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 329763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/29/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• 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: Required Intervention
• Patient Sex: Unknown