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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received at csi for analysis.Analysis revealed some adhered and embedded biological material on and within the driveshaft filars and crown of the device.The adhered material prevented a test wire from passing through.The morphology of the biological material is not known.The exact root cause of accumulating tissue remains unknown.Examination in the areas of the adhered tissue did not reveal any device damage that would have contributed to the accumulation.At the conclusion of the failure analysis investigation the reported event was not confirmed.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 peripheral orbital atherectomy device (oad) was used to complete four treatments on low speed.The extent of the calcification was moderate and the vessel was 60% stenotic.Once the oad advanced past the lesion, the speed setting was increased to high, and the device stopped spinning.Despite troubleshooting, the device would not start spinning again.The oad was removed so that imaging could be performed to assess the vessel.Imaging showed a dissection was present near the area of treatment.A balloon was used to successfully resolve the dissection.The patient was well upon completion of the procedure.

• 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
• MDR Report Key: 7960343
• Report Number: 3004742232-2018-00304
• Device Sequence Number: 10813324
• Product Code: MCX
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)200731(10)233777
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2018

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: 07/31/2020
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 233777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/12/2018
• 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: Required Intervention