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	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported guide wire was returned in two pieces for analysis.A visual examination confirmed that the guide wire core was fractured.The guide wire spring tip was found to be damaged and deformed but intact.Scanning electron microscopy analysis was performed on the fractured wire segments and showed an appearance consistent with the wire making contact with a hard surface, which caused narrowing of the outside diameter of the fracture site.This can occur as the result of the device spinning over a bend or kink in the guide wire, which can cause excessive wear and an eventual fracture of the guide wire.It is hypothesized that the galling over the kink in the guide wire caused a weak point which led to a fracture upon the firm pulling by the physician which was reported during the procedure.The instructions for use (ifu) for the reported device state "do not operate the device if there is a bend, kink, or tight loop in the guide wire.A bend, kink, or tight loop in the guide wire may cause damage to and malfunctioning of the device during use." the material inspection report for this guide wire 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.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure, the viperwire guide wire became detached.Following atherectomy treatment, the diamondback orbital atherectomy device (oad) was removed from the patient.The viperwire was noted to have moved into a contralateral vessel, and when the wire was retracted it was found to be tight within the sheath.The wire was pulled firmly and was noted to become detached 15 cm above the access site.The body of the wire was removed and the detached portion of the wire was removed with a snare.The procedure was completed with balloon angioplasty and there was no injury to the patient.

• 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: 8363252
• Report Number: 3004742232-2019-00061
• Device Sequence Number: 13942878
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)200930(10)243550
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/22/2019

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: 09/30/2020
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 243550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/22/2019
• 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
• Patient Age: 65 YR