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

Catalog Number	504610T
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	10/15/2025
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, a 10f avanti+ sheath introducer w/o mini gw 23cm fragmented into two distinct pieces during routine removal following pulmonary vein isolation and posterior wall isolation with pulsed field ablation, resulting in a retained foreign body that required right groin exploration with a cutdown to the right femoral vein for surgical removal.There was a reported patient injury of a retained fragment requiring surgical intervention.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a 10f avanti+ sheath introducer w/o mini gw 23cm fragmented into two distinct pieces during routine removal following pulmonary vein isolation and posterior wall isolation with pulsed field ablation, resulting in a retained foreign body that required right groin exploration with a cutdown to the right femoral vein for surgical removal.There was a reported patient injury of a retained fragment requiring surgical intervention.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for evaluation.A product history record (phr) review of lot 18500181 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿cannula-separated¿ could not be substantiated because the device was not returned for evaluation, no images were provided, and limited event details were available, preventing confirmation of the reported damage or determination of the failure mechanism.Multiple attempts to obtain additional procedural details were unsuccessful, and the device was not returned for evaluation.As a result, an assessment of the device condition at the time of the event and the use environment could not be performed.Therefore, potential handling or procedural or handling related contributing factors cannot be assessed or excluded based on the available information.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 product labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿do not introduce sharp medical instruments which can lead to device damage.If increased resistance is felt upon insertion of the sheath, stop the procedure and use fluoroscopy to determine the cause.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the sheath.¿ based on the available information, 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.; 14021 nw 60 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: 23692654
• Report Number: 9616099-2025-01924
• Device Sequence Number: 18699933
• Product Code: DRE
• UDI-Device Identifier: 10705032010214
• UDI-Public: (01)10705032010214(17)280831(10)18500181
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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: 504610T
• Device Lot Number: 18500181
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White