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

Catalog Number	504606X
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the side port of a 6f avanti plus catheter sheath introducer was blocked by clot.There was no reported patient injury.The product was stored as per labeling and was opened in sterile field.The device is expected to 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, the side port of a 6f avanti plus catheter sheath introducer was blocked by clot.There was no reported patient injury.The product was stored as per labeling and was opened in sterile field.Multiple attempts to gather additional information have been made and have been unsuccessful.The reported ¿side port extension obstructed particles/material can be injected¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Factors such as vessel anatomy, user handling, and concomitant devices could be a contributing factor additional force and manipulation of the catheter sheath introducer (csi) while in the vessel may have also been a contributing factor the reported event.If the csi is not flushed properly with heparinized saline or a suitable isotonic solution as per the instructions for use (ifu), blood flow can clot.In addition, patient factors (which were not specified), such as comorbidities and hypercoagulability could have attributed.As per the instructions for use (ifu), once the sideport has been aspirated to remove air, it should be considered to establish a heparinized saline or suitable isotonic solution via the sideport extension.The addition of a heparinized saline via the side port extension can help with the prevention of thrombus formation.The information available does not suggest a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.
Event or Problem Description
Multiple attempts to gather additional information have been made and have been unsuccessful.The device was not returned as anticipated.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 20309175
• Report Number: 9616099-2024-00322
• Device Sequence Number: 12971199
• Product Code: DRE
• UDI-Device Identifier: 10705032010054
• UDI-Public: (01)10705032010054(17)270531(10)18333205
• 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
• Report Date (Section B): 10/21/2024

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 Catalogue Number: 504606X
• Device Lot Number: 18333205
• Was Device Available for Evaluation?: Yes
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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