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

Model Number VPR-SLD2

Device Problems Product Quality Problem (1506); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

Describe event, problem, or product use error: csi viperslide lubricant and intralipid both have a similar milky white appearance and packaged similar with a white and blue port.Viperslide is a non-drug product used as a lubricant in certain procedures and intralipid is a lipid injectable emulsion.There is a risk of a potential mix up since these products look very similar.We discovered a viperslide lubricant product in the pharmacy, which was returned back to pharmacy, possibly due to the fact that it looks like the intralipid product we carry.

• Brand Name: VIPERSLIDE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 15699529
• MDR Text Key: 302922967
• Report Number: MW5112979
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/30/2023
• Device Model Number: VPR-SLD2
• Device Catalogue Number: 72031-01
• Device Lot Number: 10QK8697
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2022
• Patient Sequence Number: 1