MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPERCATH XC; CATHETER, PERCUTANEOUS

Model Number	035-XC-200-0
Medical Device Problem Codes	Break (1069); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
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 that during removal of the vipercath xc exchange catheter during treatment via radial access, air was observed suspecting a hole in the vipercath.The issue was observed when the physician drew the syringe back to confirm if the blood was getting back and it was filled with air.The contrast was not injected through the catheter because of the air coming back.There was no air present inside the patient.The vipercath was removed from patient and a new vipercath was used to complete the procedure without any adverse effects to the patient.No damage was observed to the vipercath upon removal.The patient was stable.
Event or Problem Description
It was reported that during removal of the vipercath xc exchange catheter during treatment via radial access, air was observed suspecting a hole in the vipercath.The issue was observed when the physician drew the syringe back to confirm if the blood was getting back and it was filled with air.The contrast was not injected through the catheter because of the air coming back.There was no air present inside the patient.The vipercath was removed from patient and a new vipercath was used to complete the procedure without any adverse effects to the patient.No damage was observed to the vipercath upon removal.The patient was stable.
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 provided, a definitive cause for the reported break and air in device could not be determined.In this case, it is likely that the break and air in device is a result of use or handling techniques employed; however, since the device was not returned this could not be 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: g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions) and h11.

• Brand Name: VIPERCATH XC
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 20991003
• Report Number: 3004742232-2024-01033
• Device Sequence Number: 8466265
• Product Code: DQY
• UDI-Device Identifier: 10852528005688
• UDI-Public: (01)10852528005688(17)251031(10)511410
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K211251
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 10/31/2025
• Device Model Number: 035-XC-200-0
• Device Catalogue Number: 7-10043-01
• Device Lot Number: 511410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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