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

Model Number	VPR-SLD2
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
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.Variance permits numbering sequence to deviate from the definition of a manufacturer report number found in 21 cfr part 803.3 (m)(3), to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
It was reported a viperslide integrity indicator turned black.It was indicated the viperslide pouch had no visible damage.There was no patient involvement.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis was performed on the returned device.The reported complaint of unsealed device packaging - sterility breached 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, a definitive cause for the reported unsealed device packaging - sterility breached could not be determined.A cut or puncture was observed on the bottom corner of the pouch, resulting in the integrity indicator turning black.The cause of the damage is unknown.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.Variance permits numbering sequence to deviate from the definition of a manufacturer report number found in 21 cfr part 803.3 (m)(3), to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
It was reported a viperslide integrity indicator turned black.It was indicated the viperslide pouch had no visible damage.There was no patient involvement.

• Brand Name: VIPERSLIDE
• 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, #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: 21028217
• Report Number: 3004742232-2024-01034
• Device Sequence Number: 18413851
• Product Code: MCW
• UDI-Device Identifier: 10852528005121
• UDI-Public: (01)10852528005121(17)250430(10)10SE1224
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K111388
• Exemption Number: GEN2400518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 04/30/2025
• Device Model Number: VPR-SLD2
• Device Catalogue Number: VPR-SLD2
• Device Lot Number: 10SE1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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