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

Catalog Number	504611X
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
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, two parts of an 11f 11cm avanti+ catheter sheath introducer (csi) separated from each other and the csi reportedly failed part way through robotic cardiac surgery procedure.There was no reported patient injury.Packaging and lot numbers were not available for retrieval.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, two parts of an 11f 11cm avanti+ catheter sheath introducer (csi) separated from each other and the csi reportedly failed part way through robotic cardiac surgery procedure.There was no reported patient injury.Packaging and lot numbers were not available for retrieval.Multiple attempts to obtain supplemental information were made; however, additional event details were not available.The device will not be returned for evaluation.A product history record (phr) review of lot 18500965 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 for evaluation, no images were provided, and limited event details were available, preventing confirmation of the reported damage or determination of the failure mechanism.As a result, the investigation was limited to a review of available documentation and manufacturing history.Although the cause of the reported event remains undetermined, the investigation did not identify evidence of a new or increased residual risk beyond those already addressed by existing risk controls.Based on the available information, there is no evidence to suggest the event is related to the device design or manufacturing process; therefore, no further action 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 FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23697501
• Report Number: 9616099-2025-01926
• Device Sequence Number: 10216039
• Product Code: DRE
• UDI-Device Identifier: 10705032010252
• UDI-Public: (01)10705032010252(17)280831(10)18500965
• 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: 504611X
• Device Lot Number: 18500965
• 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: 09/11/2025
• 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 Sex: Unknown