MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERCATH XC PERIPHERAL EXCHANGE CATHETER; PERCUTANEOUS CATHETER

Model Number	035-XC-200-1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A vipercath xc peripheral exchange catheter fractured in a sheath and became stuck in the popliteal artery at complete total occlusion.Several unsuccessful attempts were made with a non-csi device to retrieve the catheter.The fractured component was stuck in the vessel.The patient was transferred to another hospital for an endarterectomy to remove the catheter.
Additional Manufacturer Narrative
The catheter was returned to csi.Visual analysis revealed a fracture in the catheter located 62cm from the end of the strain relief.The fractured distal portion was not returned for analysis.Torsional damage at the fracture site was observed.This can occur due to stresses applied during use.The exact root cause of the fracture was unable to be determined.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(4).

• Brand Name: VIPERCATH XC PERIPHERAL EXCHANGE CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16961346
• Report Number: 3004742232-2023-00142
• Device Sequence Number: 5216758
• Product Code: DQY
• UDI-Device Identifier: 10852528005695
• UDI-Public: (01)10852528005695(17)250228(10)472942
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183000
• 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
• Report Date (Section B): 05/19/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 035-XC-200-1
• Device Catalogue Number: 7-10043-02
• Device Lot Number: 472942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White