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

Catalog Number	504606X
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	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a portion of a 6f avanti plus std 11cm.038-inch introducer fractured during sheath removal and remained inside the patient during an electrophysiology procedure.The retained fragment was subsequently removed by vascular surgery.There was no reported patient injury.The lot is unknown.The device will be returned for evaluation.
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.
Additional Manufacturer Narrative
As reported, a portion of a 6f avanti plus std 11cm.038-inch introducer fractured during sheath removal and remained inside the patient during an electrophysiology procedure.The retained fragment was subsequently removed by vascular surgery.There was no reported patient injury.The lot is unknown.The intended procedure was a radiofrequency ablation (rfa).No other avanti plus was used, and the product was stored, handled, and prepped according to the instructions for use (ifu) with no device damage noted before opening, no difficulty removing it from sterile packaging, and no issues during preparation.The separated cannula or needle did not remain on the wire or within the sheath, and after the patient was transferred to the vascular surgery department, it was surgically removed.The device was not returned, no procedural images were available for review, and the lot number is unknown so a phr could not be performed.The reported ¿cannula ¿ separated¿ could not be confirmed because the device was not returned and images were not provided.In addition, the lot number is unknown; therefore, a product history review could not be performed.Therefore, the exact cause of the reported event could not be determined.Because no device damage was noted prior to insertion, procedural and handling factors cannot be excluded.Users are trained to inspect for signs of damage prior to and during use, and any product with damage is not to be used.Information for safety is provided in the product labeling to make the user aware of relevant risks.According to the instructions for use (ifu), this product is intended to be used by a trained professional using a standard catheterization technique, includes precautions to avoid device damage, and states that complications may occur at any time during or after the procedure.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.

• 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: 24281001
• Report Number: 9616099-2026-00211
• Device Sequence Number: 9963143
• Product Code: DRE
• UDI-Device Identifier: 10705032010054
• UDI-Public: (01)10705032010054
• 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): 03/07/2026

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: 504606X
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/22/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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