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

Model Number	VPR-GW-FLEX14
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during peripheral intervention of the left leg via right femoral artery & left posterior tibial (pt) pedal access, a viperwire peripheral guidewire was advanced down into the distal peroneal artery.The 1.25 solid diamondback peripheral orbital atherectomy device (oad) was placed over the viperwire guidewire to treat the tibioperoneal (tp) trunk and down to about the mid-peroneal.At some point between checking the viperwire guidewire tip placement and then actually starting the treatment, the guidewire was pulled back and then advanced deep into a collateral.During first treatment, a slack in the viperwire guidewire was noticed on the flouroscopy monitor.The guidewire fractured and the oad automatically shut off.The oad was removed, two guidewire fragments left in-vivo.The majority of the tip of the viperwire guidewire spring tip was lodged deep into a collateral off of the peroneal.A small piece of wire fragment was at the distal to the takeoff of the peroneal.Multiple snares were used to try and remove the fragments but were unsuccessful.At this point it was noticed that the small proximal fragment piece was mostly occlusive and there was no flow in either the pt or peroneal.An esprit 3.5x38 was placed starting in the tp trunk and crossing the peroneal/pt bifurcation into the peroneal artery to trap the piece of wire against the wall which successfully in re-established flow into the peroneal.Left pedal pt access was then obtained to try and re-open the pt.A 014 command wire was placed up through the pt and passed through the scaffold struts into the popliteal artery.Additional dilatation was performed to post-dilate to a larger size than what had previously.A 2.0x40 jade balloon was used to balloon open the scaffold strut to get flow back into the pt.After that the peroneal and pt bifurcation was ballooned simultaneously using a "kissing balloon" technique.The complication added significant time to the procedure.The procedure was successfully completed with three vessel runoff.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis and detailed analysis were performed on the returned device.The reported guide wire fracture is confirmed.The reported patient effects could not be confirmed through analysis.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 guide wire fracture appears to be related to circumstances of the procedure.The guide wire was returned fractured 317.5cm from the proximal end.Sem analysis of the guide wire core shows evidence of ductile torsion.The wire segment leading up to fracture is twisted due to the torque applied.It is hypothesized that the oad fracture resulted in high friction with the guide wire leading to the torsion condition and eventual fracture.However, this is not confirmed.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.Updated fields: b5, d9, g3, g6, h2, h3, h6 (component code, type of investigation, investigation findings, investigation conclusions) correction: g1.
Event or Problem Description
It was reported that during peripheral intervention of the left leg via right femoral artery & left posterior tibial (pt) pedal access, a viperwire peripheral guidewire was advanced down into the distal peroneal artery.The 1.25 solid diamondback peripheral orbital atherectomy device (oad) was placed over the viperwire guidewire to treat the tibioperoneal (tp) trunk and down to about the mid-peroneal.At some point between checking the viperwire guidewire tip placement and then actually starting the treatment, the guidewire was pulled back and then advanced deep into a collateral.During first treatment, a slack in the viperwire guidewire was noticed on the flouroscopy monitor.The guidewire fractured and the oad automatically shut off.The oad was removed, two guidewire fragments left in-vivo.The majority of the tip of the viperwire guidewire spring tip was lodged deep into a collateral off of the peroneal.A small piece of wire fragment was at the distal to the takeoff of the peroneal.Multiple snares were used to try and remove the fragments but were unsuccessful.At this point it was noticed that the small proximal fragment piece was mostly occlusive and there was no flow in either the pt or peroneal.An esprit 3.5x38 was placed starting in the tp trunk and crossing the peroneal/pt bifurcation into the peroneal artery to trap the piece of wire against the wall which successfully in re-established flow into the peroneal.Left pedal pt access was then obtained to try and re-open the pt.A 014 command wire was placed up through the pt and passed through the scaffold struts into the popliteal artery.Additional dilatation was performed to post-dilate to a larger size than what had previously.A 2.0x40 jade balloon was used to balloon open the scaffold strut to get flow back into the pt.After that the peroneal and pt bifurcation was ballooned simultaneously using a "kissing balloon" technique.The complication added significant time to the procedure.The procedure was successfully completed with three vessel runoff.

• Brand Name: VIPERWIRE ADVANCE FLEXTIP
• 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: 23028417
• Report Number: 3004742232-2025-00265
• Device Sequence Number: 9427915
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)270228(10)566631-2
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 10/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 566631-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: Black Or African American