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

Model Number	VPR-GW-FT14
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/20/2018
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.Csi id: (b)(4).
Event or Problem Description
Difficulty was encountered during advancement of the viperwire into the distal anterior tibial artery.The vessel exhibited 100% stenosis, and the lesion of interest was type b.Seven treatments were completed with the orbital atherectomy device (oad).During the last treatment, the oad became stuck but was eventually retracted.Difficulty was encountered during removal of the viperwire since it was stuck in a calcified region of the vessel.During attempts to remove the wire, it fractured.The intact portion of the wire was removed, the vessel was re-wired, and the procedure was continued.The fragment was left in vivo, and a stent was used to fix the fragment to the vessel wall.The procedure concluded with good results and the patient was stable.
Additional Manufacturer Narrative
The viperwire was received at csi for analysis.The fractured guide wire section was returned without the spring tip section or orbital atherectomy device (oad).The proximal end of the distal core section exhibited two bends or kinks in the shaft located near the distal end.Scanning electron microscopy analysis of the guidewire revealed post fracture smearing on the face and "v" shaped surface, which indicates the device may have been bent to the point of fracture.At the conclusion of the failure analysis investigation, the wire fracture event was partially confirmed through analysis, but the exact cause of the guide wire damage and fracture could not be determined.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.Prior to distribution the device met material, assembly, and quality control requirements.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8195960
• Report Number: 3004742232-2018-00380
• Device Sequence Number: 1693628
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)200630(10)234376
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151260
• 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): 01/19/2019

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: 06/30/2020
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 234376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/19/2019
• 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: Other
• Patient Weight: 57