MAUDE Adverse Event Report: CORDIS US. CORP AVANTI; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	504605S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the proximal end of the vessel dilator for a 5f 7.5cm avanti plus catheter sheath introducer (csi) broke off in the sheath when removing the dilator.There were no reported patient injuries.The device was stored and prepared in accordance with the instructions for use (ifu) and was kept in the procedure room prior to the procedure.The facility does not use room sterilization methods involving ultraviolet light or o zone.There was no visible damage to the packaging prior to use.There was no difficulty inserting the dilator into the sheath, the luer hub did not kink or bend during insertion, and the dilator was snapped into place at the hub prior to insertion of the sheath.The access vessel was the right femoral vein, which was not calcified or tortuous and had no other noted characteristics.No difficulty was experienced during insertion of the sheath and dilator into the patient, and there was no difficulty withdrawing the dilator from the sheath prior to the separation occurring.The device will be returned for evaluation along with 27 sterile units.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the proximal end of the vessel dilator for a 5f 7.5cm avanti plus catheter sheath introducer (csi) broke off in the sheath when removing the dilator.There were no reported patient injuries.The device was stored and prepared in accordance with the instructions for use (ifu) and was kept in the procedure room prior to the procedure.The facility does not use room sterilization methods involving ultraviolet light or o zone.There was no visible damage to the packaging prior to use.There was no difficulty inserting the dilator into the sheath, the luer hub did not kink or bend during insertion, and the dilator was snapped into place at the hub prior to insertion of the sheath.The access vessel was the right femoral vein, which was not calcified or tortuous and had no other noted characteristics.No difficulty was experienced during insertion of the sheath and dilator into the patient, and there was no difficulty withdrawing the dilator from the sheath prior to the separation occurring.The device will not be returned for evaluation; however, 23 sterile units were returned.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 24777075
• Report Number: 9616099-2026-00451
• Device Sequence Number: 6134265
• Product Code: DRE
• UDI-Device Identifier: 10705032009966
• UDI-Public: (01)10705032009966(17)281031(10)18531094
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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
• Device Catalogue Number: 504605S
• Device Lot Number: 18531094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 03/23/2026; 05/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/17/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Weight: 4 KG