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

Catalog Number	504615Z
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	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 5f 11cm avanti plus trans-radial catheter sheath introducer (csi) could not pass during use.There were no reported injuries to the patient.Additional information was requested but was not provided.The device will be returned for evaluation.Addendum: the device was returned with the vessel dilator separated.
Event or Problem Description
As reported, a 5f 11cm avanti plus trans-radial catheter sheath introducer (csi) could not pass during use.There were no reported injuries to the patient.This was during an angiography procedure.There was no calcification or tortuosity at the insertion site.The device was stored and prepped per the instructions for use (ifu).There were no patient-specific anatomical anomalies at the insertion site.The vessel dilator was snapped into place at the hub, and the csi was wiped down with a wet gauze prior to insertion.There was no damage to the csi noted after removal.Additional details were requested but were not provided.The device will be returned for evaluation.Addendum: the device was returned with the vessel dilator separated.It was reported the vessel dilator was not within the sheath when it separated.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 5f 11cm avanti plus trans-radial catheter sheath introducer (csi) could not pass during use.There were no reported injuries to the patient.This was during an angiography procedure.There was no calcification or tortuosity at the insertion site.The device was stored and prepped per the instructions for use (ifu).There were no patient-specific anatomical anomalies at the insertion site.The vessel dilator was snapped into place at the hub, and the csi was wiped down with a wet gauze prior to insertion.There was no damage to the csi noted after removal.Additional details were requested but were not provided.A non-sterile unit of ¿si avanti+ transrad kit 11cm¿ was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The components returned are the vessel dilator and the catheter sheath introducer (csi).The vessel dilator was separated into two pieces, with the separation located approximately 15 cm from the distal tip.A kinked condition was observed on the vessel dilator where the body joins the hub.The csi did not present any damages or anomalies.No other outstanding details were observed on the analyzed parts.Dimensional analysis was performed near the separated area to verify the correct id and od of the vessel dilator, with results found to be within specification.Functional analysis confirmed that the csi allowed water flow through the distal tip without resistance or loose material.A lab sample vessel dilator and guidewire were successfully inserted and withdrawn through the csi without obstruction.Magnified inspection of the vessel dilator confirmed the kinked condition and revealed fatigue striations and plastic deformation on the separated surface.These features are consistent with material tensile overload, suggesting that the vessel dilator was subjected to a tensile force exceeding the material's yield strength prior to separation.The product analysis did not provide evidence to suggest that the observed damages were related to the manufacturing or design process.The reported event ¿catheter sheath introducer, insertion difficulty¿ could not be substantiated during the evaluation because this event cannot be replicated in a laboratory environment.Additionally, the malfunction ¿vessel dilator-separated¿ was discovered during the product evaluation.Patient anatomy may have created insertion difficulties and continued use of the device against excessive resistance may have played a role in the separation.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if the device becomes kinked or increased resistance is felt upon insertion or advancement of the vessel dilator, investigate the cause before continuing.¿ and ¿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 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, a 5f 11cm avanti plus trans-radial catheter sheath introducer (csi) could not pass during use and the vessel dilator separated when entering the vessel.There were no reported injuries to the patient.This was during an angiography procedure.There was no calcification or tortuosity at the insertion site.The device was stored and prepped per the instructions for use (ifu).There were no patient-specific anatomical anomalies at the insertion site.The vessel dilator was snapped into place at the hub, and the csi was wiped down with a wet gauze prior to insertion.There was no damage to the csi noted after removal.Additional details were requested but were not provided.A non-sterile unit of ¿si avanti+ transrad kit 11cm¿ was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The components returned are the vessel dilator and the catheter sheath introducer (csi).The vessel dilator was separated into two pieces, with the separation located approximately 15 cm from the distal tip.A kinked condition was observed on the vessel dilator where the body joins the hub.The csi did not present any damages or anomalies.No other outstanding details were observed on the analyzed parts.Dimensional analysis was performed near the separated area to verify the correct id and od of the vessel dilator, with results found to be within specification.Functional analysis confirmed that the csi allowed water flow through the distal tip without resistance or loose material.A lab sample vessel dilator and guidewire were successfully inserted and withdrawn through the csi without obstruction.Magnified inspection of the vessel dilator confirmed the kinked condition and revealed fatigue striations and plastic deformation on the separated surface.These features are consistent with material tensile overload, suggesting that the vessel dilator was subjected to a tensile force exceeding the material's yield strength prior to separation.The product analysis did not provide evidence to suggest that the observed damages were related to the manufacturing or design process.The reported event ¿catheter sheath introducer ¿ insertion difficulty¿ was not substantiated during the evaluation because this event cannot be replicated in a laboratory environment.However, the malfunction ¿vessel dilator-separated¿ was seen during the product evaluation.Inserting the device against excessive resistance may have played a role in the separation.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if the device becomes kinked or increased resistance is felt upon insertion or advancement of the vessel dilator, investigate the cause before continuing.¿ and ¿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 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.
Event or Problem Description
As reported, a 5f 11cm avanti plus trans-radial catheter sheath introducer (csi) could not pass during use and the vessel dilator separated when entering the vessel.There were no reported injuries to the patient.This was during an angiography procedure.There was no calcification or tortuosity at the insertion site.The device was stored and prepped per the instructions for use (ifu).There were no patient-specific anatomical anomalies at the insertion site.The vessel dilator was snapped into place at the hub, and the csi was wiped down with a wet gauze prior to insertion.There was no damage to the csi noted after removal.Additional details were requested but were not provided.The device will be returned for evaluation.

• Brand Name: AVANTI TRANSRADIAL
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 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: 22043525
• Report Number: 9616099-2025-00849
• Device Sequence Number: 15648931
• Product Code: DRE
• UDI-Device Identifier: 10705032010276
• UDI-Public: (01)10705032010276(17)270331(10)18307862
• 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): 07/09/2025

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
• Device Catalogue Number: 504615Z
• Device Lot Number: 18307862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/25/2025; 07/01/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/11/2025; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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 BALLOON.; UNKNOWN GUIDE CATHETER.
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 76 KG