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

Model Number	VPR-GW-FLEX14
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The guide wire was returned to csi for analysis and a fracture was located 330cm from the proximal end.Scanning electron microscopy (sem) analysis of the fractured face shows evidence of torsional failure.This damage is consistent when extreme and/or abnormal stress condition exist in the fractured location, although,the exact root cause was unable to 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.The device met material, assembly, and quality control requirements.H6 investigation conclusion code 22: the stealth 360® peripheral orbital atherectomy system instructions for user manual states that a perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.
Event or Problem Description
A stealth 360 peripheral orbital atherectomy device was used for treatment of the popliteal artery, tibioperoneal trunk (tpt), and peroneal artery.One treatment on low speed was performed in three treatment segments.The oad and tip of the driveshaft remained greater than 100mm from the spring tip.During oad removal, the oad pulled the viperwire advance guide wire out of position.Post oad treatment, a jade balloon was used in the popliteal and a non-csi balloon was used in the tpt and peroneal.Upon removal of the balloon, the spring tip was noted to be separated from the body of the viperwire.The remaining viperwire was exchanged for a non-csi wire.Additional interventions were made with non-csi devices.Angiographic imaging was observed, and a perforation was noted in the distal external iliac/proximal common femoral artery (cfa).Balloon tamponade was unsuccessful.Three covered stents were placed in the distal external iliac/proximal cfa with resolution of contrast extravasation.The viperwire spring tip remained in the distal peroneal.The patient was transferred to the hospital for further testing and monitoring.The patient was in stable condition.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE (VIPERWIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16989317
• Report Number: 3004742232-2023-00146
• Device Sequence Number: 6791070
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)241130(10)460354-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 11/30/2024
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 460354-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White