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

Catalog Number	402610X
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	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during the puncture of the patient's right femoral vein, a 10f 11 cm avanti plus sheath introducer broke into two (2) parts upon removal, with one segment remaining inside the vein.The retained fragment was not visible via fluoroscopy, ultrasound, or transesophageal echocardiography and therefore remained lodged in the vessel.The patient was immediately transferred under anesthesia to the cardiothoracic center for surgical removal.A photograph has been enclosed for review.The device is expected to be returned for further evaluation.
Additional Manufacturer Narrative
As reported, during the puncture of the patient's right femoral vein, a 10f 11 cm avanti plus sheath introducer broke into two (2) parts upon removal, with one segment remaining inside the vein.The retained fragment was not visible via fluoroscopy, ultrasound, or transesophageal echocardiography and therefore remained lodged in the vessel.The patient was immediately transferred under anesthesia to the cardiothoracic center for surgical removal.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for further evaluation as anticipated.One image was submitted showing a 10f cordis csi with an inserted guidewire and a separated cannula presenting plastic elongations.No other anomalies were observed.The photos/videos do not provide sufficient information to determine whether there is a manufacturing-related issue or not, the information is insufficient to draw any further conclusions.A product history record (phr) review of lot 18448388 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 (csi)-separated¿ was seen during the product evaluation.A separation was noted to the cannula of the device.The root cause cannot be determined with the information provided and the image that was submitted for review.Additionally, no conclusions can be drawn regarding user compliance with the instructions for use.Based on the available information and product analysis, 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.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18448388 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
The device was not returned.

• 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
• 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: 22755553
• Report Number: 9616099-2025-01281
• Device Sequence Number: 9364341
• Product Code: DRE
• UDI-Device Identifier: 10705032000765
• UDI-Public: (01)10705032000765(17)280430(10)18448388
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 402610X
• Device Lot Number: 18448388
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 09/04/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/04/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• 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