MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504608T
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sheath broke apart when placed on wire.8f avanti 23cm cordis was being placed over the wire when the md noticed a piece of the one way valve had come apart.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave; miami lakes FL 33014
• MDR Report Key: 24952965
• Report Number: 24952965
• Device Sequence Number: 14762809
• Product Code: DRE
• UDI-Device Identifier: 10705032010139
• UDI-Public: (01)10705032010139
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2026
• Report Date (Section F): 04/07/2026

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: Other
• Device Model Number: 504608T
• Device Catalogue Number: 504608T
• Device Lot Number: 18552205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/07/2026