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	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during preparation 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 according to the instructions for use (ifu), and it was kept in the procedure room prior to the procedure.The facility does not use sterilization methods involving ultraviolet light or o-zone.There was no visible damage to the packaging before use.No difficulty was encountered when inserting the dilator into the sheath, and the luer hub did not kink or bend during insertion.The dilator was snapped into place at the hub.The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d9, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, during preparation 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 according to the instructions for use (ifu), and it was kept in the procedure room prior to the procedure.The facility does not use sterilization methods involving ultraviolet light or o-zone.There was no visible damage to the packaging before use.No difficulty was encountered when inserting the dilator into the sheath, and the luer hub did not kink or bend during insertion.The dilator was snapped into place at the hub.The device was not returned for evaluation.A product history review (phr) of lot 18531094 was completed, and it does not suggest that the failure experienced by the customer could be related to the manufacturing process.The reported ¿vessel dilator ¿ separated¿ could not be substantiated because the device was not returned and images were not provided.The exact cause of the reported event cannot be determined, and use-related factors cannot be excluded.The device is intended for use by trained professionals using standard catheterization technique.Information for safety is provided in the product labeling to make users aware of applicable risks and precautions.According to the instructions for use (ifu), ¿this product is intended to be used by a trained professional using a standard catheterization technique.¿ based on the available information, there is no evidence to suggest the reported event is related to manufacturing or design issues.Therefore, no additional actions will be taken.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during preparation 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 according to the instructions for use (ifu), and it was kept in the procedure room prior to the procedure.The facility does not use sterilization methods involving ultraviolet light or o-zone.There was no visible damage to the packaging before use.No difficulty was encountered when inserting the dilator into the sheath, and the luer hub did not kink or bend during insertion.The dilator was snapped into place at the hub.The device will be returned for evaluation.

• 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: 24777127
• Report Number: 9616099-2026-00452
• Device Sequence Number: 6065150
• 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
• Report Date (Section B): 05/06/2026

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?: No
• 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: 04/15/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 2 KG