MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number	VPR-GW-14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2020
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.The atherectomy device used in the case also fractured.This has been captured and submitted in mdr 3004742232-2020-00375.(b)(4).
Event or Problem Description
Proximal to distal treatment with a viperwire guide wire was performed in the peroneal artery.Imaging showed vessel spasm, but treatment was continued.Due to an issue with the atherectomy device, the viperwire was pulled back, and the tip of the wire fractured.The patient was sent to surgery for removal of the fragment.The patient made a full recovery following removal of the fragments.In the opinion of the physician, the crown selected was too big for the vessel, and oa should not have been used during spasm.
Additional Manufacturer Narrative
Device analysis conclusion: the guide wire was received at csi for analysis engaged in the orbital atherectomy device (oad).Visual examination revealed a spring tip protrusion from the driveshaft filars of the oad.The guide wire spring tip proximal solder bond and coil exhibited rotational surface damage.However, no fractures were observed.The guide wire and spring tip section were destructively removed from the driveshaft and handle assembly.After removal, it appeared fractured spring tip coils were present.This damage may have been incurred during the removal; however, that could not be confirmed.Scanning electron microscopy analysis of the spring tip confirmed axial surface damage on the proximal spring tip coils.Based on the event details reported to csi, it is hypothesized that the guidewire was pulled into the driveshaft during the user's attempts to remove the oad.This may have given the appearance that the spring tip had fractured completely, though analysis shows it did not.The exact root cause of the fractures could not be determined.At the conclusion of the device analysis investigation, the report that the wire fractured was confirmed, but the root cause of the fracture could not be confirmed through analysis.Furthermore, the report that the wire tip fractured completely was not confirmed; the fractures observed were not indicative of a complete tip fracture.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.A complaint was reported related to an oad used in this procedure.That event has been captured in mdr 3004742232-2020-00375.Csi id: (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 10881617
• Report Number: 3004742232-2020-00376
• Device Sequence Number: 14260024
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)220331(10)323994
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 03/31/2022
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 323994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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