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

Catalog Number	402606P
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, foreign material was observed between the threading on the hub of a 6f avanti plus sheath introducer after the device was dropped on the field.The sheath was immediately removed from the field upon identification of the residue during flushing and preparation for use.There was no reported patient injury.Two images were provided for reference, showing the proximal portion of the green vessel dilator with residue on the hub and the corresponding product packaging.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, foreign material was observed between the threading on the hub of a 6f avanti plus sheath introducer after the device was dropped on the field.The sheath was immediately removed from the field upon identification of the residue during flushing and preparation for use.There was no reported patient injury.Two images were provided for reference, showing the proximal portion of the green vessel dilator with residue on the hub and the corresponding product packaging.Multiple attempts were made to obtain supplemental information; however, no additional event details were provided.The device was not returned for evaluation as anticipated.A picture was attached for evaluation, and the graphic material shows a 6f vessel dilator with an observed amount of yellowish matter; however, no additional details could be observed in the images provided.The photo does not provide sufficient information to determine whether a design- or manufacturing-related issue is present, and the available information is insufficient to draw further conclusions; therefore, no actions were taken at this time.A product history record (phr) review of lot 18456134 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "vessel dilator ¿ foreign material" was found during photo analysis of the returned information.The foreign material was seen after the device was reportedly dropped on the sterile field; therefore, it cannot be determined when the material was introduced, and handling-related factors cannot be excluded.Review of the device labeling confirmed that no specific warnings related to user experience are included beyond the precaution stating that the device is intended for use only by physicians trained and experienced in diagnostic and interventional catheterization techniques.Based on the available information, including the photo review and product history record review, there is no evidence to indicate that the reported event is attributable to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23488900
• Report Number: 9616099-2025-01769
• Device Sequence Number: 8671943
• Product Code: DRE
• UDI-Device Identifier: 10705032000598
• UDI-Public: (01)10705032000598(17)280430(10)18456134
• 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): 12/22/2025

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 Catalogue Number: 402606P
• Device Lot Number: 18456134
• Was Device Available for Evaluation?: Yes
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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 Sex: Unknown