MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE); CORONARY 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	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Following atherectomy treatment for calcified vessels, while removing the viperwire advance guide wire through a non-csi catheter, the tip fractured.The tip fragment separated inside the balloon catheter.The physician removed the balloon and wire.The patient experienced no complication resulting from this event.The patient was in stable condition following the procedure.
Additional Manufacturer Narrative
The oad was returned to csi for analysis.The reported guide wire fracture was confirmed.The guide wire spring tip was returned lodged within a damaged non-csi catheter.Destructive analysis found two fractured sections of the spring tip.The full 3cm of spring tip was retrieved and accounted for with no missing fragments.Scanning electron microscopy analysis identified fatigue striations at the site of tensile failure.The root cause of the fracture is considered to be an external factor impacting device performance.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.(b)(4).
Additional Manufacturer Narrative
Csi id: (b)(4).
Event or Problem Description
Four to five atherectomy treatments were performed in a lesion in the approximately 90% stenosed, calcified, right posterior tibial artery on low and medium speed.Glideassist was activated also.While removing the viperwire advance peripheral guide wire through a bard.014 balloon catheter, the tip fractured.The tip fragment separated inside the balloon catheter.The physician removed the balloon catheter and wire.The patient experienced no complication resulting from this event.The patient was in stable condition following the procedure.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE)
• Common Device Name: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 15566486
• Report Number: 3004742232-2022-00223
• Device Sequence Number: 2984702
• Product Code: MCX
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)240228(10)425423-1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 425423-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2022
• 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
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White