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

Catalog Number	504605X
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	02/09/2024
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, the dilator of a 5f avanti plus sheath introducer with mini-guidewire broke when the doctor put it in the patient.The doctor tried again with a second 5f avanti sheath of the same lot and the same issue occurred.There was no reported patient injury.Femoral access was used.The intended procedure was not provided.It is unknown how the physician removed the dilator.Two (2) device pictures were received for review.Images attached to event show two dilators, which have been separated at the proximal end.There were no abnormalities noted on the product or product package.Additional event details were requested; however, not provided.The devices will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, the dilator of a 5f avanti plus sheath introducer with mini-guidewire broke when the doctor put it in the patient.The doctor tried again with a second 5f avanti sheath of the same lot and the same issue occurred.There was no reported patient injury.Femoral access was used.The intended procedure was not provided.It is unknown how the physician removed the dilator.There were no abnormalities noted on the product or product package.Two pictures were submitted for analysis.The pictures included the device packaging, which included catalogue number 504-605x and lot number 18078557 on the packaging of two units.Additionally, both vessel dilators were observed separated near the hub.The reported ¿vessel dilator-separated¿ was confirmed for both devices by picture analysis however, the exact cause of the event cannot be determined without returning the device for analysis.Handling factors may have contributed to the reported event.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 to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.If increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• 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 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18849974
• Report Number: 9616099-2024-00076
• Device Sequence Number: 20716093
• Product Code: DRE
• UDI-Device Identifier: 10705032009980
• UDI-Public: (01)10705032009980(17)251231(10)18078557
• 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): 08/15/2024

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 504605X
• Device Lot Number: 18078557
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 04/01/2024; 08/15/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/11/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2022
• 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