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

Model Number	VPR-SLD2
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
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 an expired viperslide lubricant was used knowingly.The case was successful.There were no patient complications as a result of the event.The patient was in stable condition.
Event or Problem Description
It was reported an expired viperslide lubricant was used knowingly.The case was successful.There were no patient complications as a result of the event.The patient was in stable condition.
Additional Manufacturer Narrative
H6: codes 4118, 3233, 11 no longer apply.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 improper or incorrect procedure or method - use after expiration appears to be related to user error.In this case, it is likely that the reported issue is due to intentional use of expired product.Per complaint details, "it was reported an expired viperslide lubricant was used knowingly." the viperslide instruction for use (ifu), in the storage and handling section, states: ¿use the lubricant prior to the expiration date on the shelf carton label and the individual lubricant bag label.¿ 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: 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: 21827284
• Report Number: 3004742232-2025-00082
• Device Sequence Number: 19886342
• Product Code: MCX
• UDI-Device Identifier: 10852528005121
• UDI-Public: (01)10852528005121(17)241231(10)10SA6026
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: VPR-SLD2
• Device Catalogue Number: 72031-01
• Device Lot Number: 10SA6026
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• 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: Unknown