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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
At the conclusion of an atherectomy procedure using a diamondback 360 peripheral orbital atherectomy device (oad), the physician experienced difficulty while removing the oad from the sheath.The physician identified that the oad crown remained in vivo while performing balloon angioplasty.Fluoroscopy revealed that the 1.50 crown was immobile and remained in the distal portion of the superficial femoral artery (sfa).A stent was deployed, entrapping the crown in the vessel wall.The patient's condition was stable.The procedure was completed with good flow to the lower extremity.
Additional Manufacturer Narrative
The oad was returned to csi for analysis.The reported driveshaft fracture was confirmed distal to the nose cone.The distal segment was not returned.Scanning electron microscopy analysis of the fractured filar faces identified evidence of fatigue.Fatigue may occur if the driveshaft undergoes excessive flexing due to spinning in an elevated stress environment resulting in the eventual driveshaft damage.The root cause of the fracture is unknown.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 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 14950058
• Report Number: 3004742232-2022-00158
• Device Sequence Number: 12315795
• Product Code: MCW
• UDI-Device Identifier: 10850000491196
• UDI-Public: (01)10850000491196(17)240131(10)419915-1
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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: 01/31/2024
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: 7-10057-03
• Device Lot Number: 419915-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• 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: 06/22/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: Male