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

Model Number	VPR-GW-FLEX14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The guide wire was returned for analysis.A fracture was identified at the distal end of the guide wire spring tip.The distal section of the guide wire was not returned for analysis.Scanning electron microscopy (sem) was performed on the damaged spring tip section.Sem analysis revealed evidence of rotational damage on the proximal spring tip coil.This damage evidence is consistent with the spinning oad driveshaft contacting the guide wire spring tip.The distal fracture showed evidence of ductile torsion, which is likely related to the spinning oad driveshaft contacting the guide wire spring tip.The root cause of the fracture is considered as use not consistent with the instructions for use (ifu).The ifu warns, "never advance the orbiting crown to the point of contact with the guide wire spring tip or other distal device.The maximum travel of the crown advancer knob, and therefore the shaft tip, is 15 cm.Moving the crown advancer knob forward moves the shaft tip an equal distance toward the guide wire spring tip.When moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip (or other distal device) and the distal end of the shaft (10 cm minimum).If the distance between the shaft tip and the guide wire spring tip (or other distal device) is insufficient, the shaft tip may damage the guide wire spring tip (or other distal device) and result in device or component dislodgement.Distal detachment and embolization may result".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.Csi id: (b)(4).
Event or Problem Description
A diamondback 360 peripheral orbital atherectomy device (oad) was used for treatment and then a viperwire advance guide wire fracture occurred in vivo.No further information is available.

• Brand Name: DIAMONDBACK 360 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
• 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: 19498695
• Report Number: 3004742232-2024-00205
• Device Sequence Number: 6661175
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)240531(10)434437-1
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 06/10/2024

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: 05/31/2024
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 434437-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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: Other
• Patient Sex: Unknown