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

Model Number	DBP-150CLASS145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/08/2019
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 treatment of a chronic total occlusion with a diamondback peripheral orbital atherectomy device (oad), it was difficult for the device to cross the lesion and it became stuck in both the lesion and on the guide wire.The sheath of the oad was cut and advanced over the crown in order to remove the device and the device and guide wire were removed.The lesion was re-wired and the procedure was completed with an oad of a smaller crown size.There were no patient complications reported.
Additional Manufacturer Narrative
The reported oad was received for analysis with the viperwire guide wire engaged in the device.There was no damage observed to the oad driveshaft or crown.The guide wire spring tip coils were stretched but remained intact.When attempting to remove the guide wire from the oad, significant resistance was met.A destructive analysis was performed and revealed dried biological material embedded within the driveshaft filars proximal to the crown.No damage was identified which may have contributed to the accumulation of material.The morphology and root cause of the accumulated biological material is unknown.When the returned guide wire was removed, an in-house wire was passed through the oad and met resistance at the area of embedded material.It is hypothesized that the oad driveshaft became stuck on the guide wire after seizing due to biological material accumulation.However, the root cause of the accumulated tissue remains 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 prior to distribution.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 highway 8 nw; st. paul MN 55112
• MDR Report Key: 8664140
• Report Number: 3004742232-2019-00147
• Device Sequence Number: 2118098
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)210131(10)257406
• 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): 06/10/2019

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: 01/31/2021
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: DBP¿150CLASS145
• Device Lot Number: 257406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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