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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
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
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection occurred.During treatment of a lesion in the superficial femoral artery (sfa), the device stopped spinning.Upon removal of the oad, imaging was performed and a type a dissection was noted.The guide wire was observed to be in a false lumen, and the location was corrected.Balloon angioplasty was performed and an unplanned stent was placed to resolve the dissection.The patient was in stable condition following the procedure.
Additional Manufacturer Narrative
The reported oad was received for analysis.Adhered biological material was observed on the driveshaft filars and crown.The material did not prevent a guide wire from passing through the device, and examination of the areas of adhered tissue did not reveal any damage which may have contributed to the accumulation.When tested, the device functioned as intended with no anomalies observed.It is possible that the device became wrapped in biological material which led to a stall condition, however this could not be conclusively confirmed through analysis.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).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8125965
• Report Number: 3004742232-2018-00361
• Device Sequence Number: 2324665
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)190831(10)201099
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• 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,Followup
• Report Date (Section B): 12/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 201099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/21/2018
• 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
• Patient Age: 76 YR