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

Catalog Number	504608X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a circular fragment approximately 2mm in size came off of an 8f 11cm avanti+ catheter sheath introducer (csi) while the catheter was being prepared and flushed with heparinized saline.There was no reported patient injury.The issue occurred during preparation of the device.Only one catheter experienced the issue during preparation, and all other devices from the same lot were subsequently removed from the shelf.The device had been stored and prepared according to the instructions for use (ifu), and no device or package damage was noted prior to use.There was no interaction with another device or instrument that contributed to the separation, and the user was trained in the preparation of the device.The device will not be returned for evaluation because it previously disposed of.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, a circular fragment approximately 2mm in size came off an 8f 11cm avanti+ catheter sheath introducer (csi) while the catheter was being prepared and flushed with heparinized saline.There was no reported patient injury.The issue occurred during preparation of the device.Only one catheter experienced the issue during preparation, and all other devices from the same lot were subsequently removed from the shelf.The device had been stored and prepared according to the instructions for use (ifu), and no device or package damage was noted prior to use.There was no interaction with another device or instrument that contributed to the separation, and the user was trained in the preparation of the device.The device will not be returned for evaluation because it previously disposed of.A product history record (phr) review of lot 18484614 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer ¿ 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 found.No device or package damage was noted prior to use therefore, handling factors cannot be excluded as a contributing factor.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿do not pinch the csi with forceps.It may cause scratches on it.Attention should be paid not to damage the csi with forceps or sharp-edged tools.¿ ¿do not introduce sharp medical instruments which can lead to device damage.¿ based on the available information phr review, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative 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 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: 23850602
• Report Number: 9616099-2025-02036
• Device Sequence Number: 15813767
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)280731(10)504608X
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 504608X
• Device Lot Number: 18484614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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
• Patient Ethnicity: Non Hispanic