MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERWIRE, ADVANCE; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	VPR-GW-14
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stealth 360 peripheral orbital atherectomy device (oad) was used to treat the heavily calcified, moderately tortuous, 90% stenosed right superficial femoral artery (rsfa).A 6 x 45 sheath was in use.Treatments were performed on low and medium speeds.During the high-speed treatment, the oad stalled when being pulled back.The oad became stuck on the viperwire advance peripheral guide wire.The oad and viperwire were removed and replaced to complete the procedure.There was no physical damage observed on the driveshaft or viperwire.The patient was stable.It was unknown if the issue was with the oad or viperwire.There was no clear indication as to why the oad stalled but the technician stated that the physician does not have x-ray on while spinning and may have run over the distal viperwire tip.During device analysis, a guide wire fracture was observed.
Additional Manufacturer Narrative
A visual inspection, functional testing and detailed analysis were performed on the returned device.The reported difficult to remove was confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficult to remove appears to be related to user error.There was significant resistance when attempting to remove the guide wire from the driveshaft.Further analysis found spring tip coil fragments within the distal driveshaft.The spring tip material inside the distal driveshaft indicates that the spinning driveshaft made contact with the spring tip.This is consistent with reported details which state "the physician does not have x-ray on while spinning and may have run over the distal viperwire tip." the stealth periph 1.5mm sc30 145cm oad us instruction for use (ifu) 92-10043-01 revision c), warns: ¿never advance the orbiting crown to the point of contact with the guide wire spring tip.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 ifu also precautions: ¿radiographic equipment for fluoroscopy should be used to provide high-resolution images.Use fluoroscopy to monitor movement of the shaft tip in relation to the guide wire spring tip.Guide wires, oad, and catheters should only be manipulated under fluoroscopy.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: VIPERWIRE, ADVANCE
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24830921
• Report Number: 3004742232-2026-00085
• Device Sequence Number: 10306227
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)271031(10)590377-1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K180416
• 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): 04/09/2026

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 Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 590377-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2025
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic