MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERSLIDE; CATHETER, CORONARY, ATHERECTOMY

Model Number	VPR-SLD2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following completion of treatment with 1.25 micro diamondback 360 peripheral orbital atherectomy device (oad) in the heavily calcified, mildly tortuous, over 70% stenosed posterior tibial artery (pt), the patient showed signs of anaphylactic shock including hives, nausea and low blood pressure which led to a code.The patient was kept an additional night for observation.The patient was stabilized and extubated 24 hours later.The patient was discharged the day after the procedure.The physician initially thought that the allergic reaction could be due to the viperslide lubricant solution used but further discussions with the abbott sales rep showed the patient had no listed allergies associated with the ingredients in viperslide.During follow up with the physician on the patient's status 24 hours after the procedure, the physician indicated they were unsure what caused the patient¿s reaction.
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 following completion of treatment with 1.25 micro diamondback 360 peripheral orbital atherectomy device (oad) in the heavily calcified, mildly tortuous, over 70% stenosed posterior tibial artery (pt), the patient showed signs of anaphylactic shock including hives, nausea and low blood pressure which led to a code.The patient was kept an additional night for observation.The patient was stabilized and extubated 24 hours later.The patient was discharged the day after the procedure.The physician initially thought that the allergic reaction could be due to the viperslide lubricant solution used but further discussions with the abbott sales rep showed the patient had no listed allergies associated with the ingredients in viperslide.During follow up with the physician on the patient's status 24 hours after the procedure, the physician indicated they were unsure what caused the patient¿s reaction.
Additional Manufacturer Narrative
The device was not returned for 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 information received, the investigation determined that the reported patient allergic reaction could not be determined.In this case, it is possible that the reported allergic reaction is due to an allergy to the viperslide.It should be noted that the viperslide instructions for use (ifu) contraindicates the use of the lubricant in patients with known allergies to the lubricant components listed under section 1 in the ifu.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: g3, g6, h2, h6 (codes 4118, 3233, and 11 no longer apply).

• Brand Name: VIPERSLIDE
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 24532250
• Report Number: 3004742232-2026-00043
• Device Sequence Number: 12985390
• Product Code: MCX
• UDI-Device Identifier: 10852528005121
• UDI-Public: (01)10852528005121(17)260930(10)10TK8727
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111388
• 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): 04/28/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: VPR-SLD2
• Device Catalogue Number: 72031-01
• Device Lot Number: 10TK8727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2024
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White