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
Event or Problem Description
As reported, the check valve of an 11f 11cm avanti+ catheter sheath introducer (csi) came out with the sinus catheter, and there was no way to prevent back bleeding and substantial blood loss other than quickly removing the rest of the catheter from the patient.There was no reported patient injury.This failure occurred when removing coronary sinus catheters at the conclusion of the case.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the hemostasis valve of an 11f 11cm avanti+ catheter sheath introducer (csi) separated from the catheter and was noted on the coronary sinus catheter after removal and there was no way to prevent back bleeding and substantial blood loss other than quickly removing the rest of the catheter from the patient prematurely.There was no reported patient injury.This failure occurred when removing coronary sinus catheters at the conclusion of the case.The catheter was prepped correctly by the or staff.The device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the hemostasis valve of an 11f 11cm avanti+ catheter sheath introducer (csi) separated from the catheter and was noted on the coronary sinus catheter after removal and there was no way to prevent back bleeding and substantial blood loss other than quickly removing the rest of the catheter from the patient prematurely.There was no reported patient injury.This failure occurred when removing coronary sinus catheters at the conclusion of the case.The catheter was prepped correctly by the or staff.The device was discarded and will not be returned for evaluation.Three photos were reviewed.The graphic material shows a label with catalog number 504-611x and lot number 18500965 for the sheath introducer.The images show that the cap and hemostasis valve were detached from the hub of the sheath introducer.No additional details were observable in the graphic material, and the photos/videos do not provide sufficient information to determine whether a manufacturing-related issue is present.Based on the available visual information, no further conclusions can be drawn, and no actions will be taken at this time.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 ¿hemostasis valve/hub ¿ separated¿ was substantiated by photo analysis however, the root cause cannot be determined because the device was not returned for analysis.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), to exchange catheters, slowly withdraw the catheter from the csi and repeat the insertion 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; 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: 23709016
• Report Number: 9616099-2025-01927
• Device Sequence Number: 13430272
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 12/05/2025; 02/05/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/30/2025; 02/24/2026
• 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