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

Model Number	VPR-GW-FT14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2018
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
Upon removal of the angioplasty balloon following treatment with an orbital atherectomy device (oad), it was discovered that the viperwire had fractured in more than one place.One fragment remained in the anterior tibial artery and two others remained in the dorsalis pedis artery.The fragments were removed with a combination of balloon and filter basket techniques following unsuccessful use of a snare.The patient was discharged home without complication following the procedure.
Additional Manufacturer Narrative
The guide wire was received at csi for analysis.Scanning electron microscopy analysis of the guide wire fractures revealed the presence of torsion dimples and possible fatigue shear dimples on the fracture face of the core wire faces.The core wire fracture sites also exhibited surface wear resulting in outside diameter reduction.The exact root cause could not be determined.The exact cause of the guide wire fracture is unknown.(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
• MDR Report Key: 8046185
• Report Number: 3004742232-2018-00329
• Device Sequence Number: 16540512
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)200630(10)234377
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/12/2018

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?: 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: 234377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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
• Patient Age: 61 YR
• Patient Weight: 91