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

Catalog Number	504608X
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	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported by the doctor, the hemostasis valve hub (white piece) on the 8f avanti plus sheath introducer with mini-guidewire became separated and the patient started to bleed out.The patient was fine.There was no reported patient injury.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no resistance/friction experienced during any part of the procedure nor resistance met while advancing the device.The wire was removed from the dispenser by the distal floppy end.There was no excessive torquing required.The product was removed intact (in one piece) from the patient; except for the hub which was outside the body.The separation was not related to any resistance during withdrawal of the sheath from the vessel and the sheath had not kinked or been twisted/torqued prior to the separation.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 by the doctor, the hemostasis valve hub (white piece) on the 8f avanti plus sheath introducer with mini-guidewire became separated and the patient started to bleed out.The patient was fine.There was no reported patient injury.There were no anomalies noted when the product was removed from the package.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.There was no resistance/friction experienced during any part of the procedure nor resistance met while advancing the device.The wire was removed from the dispenser by the distal floppy end.There was no excessive torquing required.The product was removed intact (in one piece) from the patient; except for the hub which was outside the body.The separation was not related to any resistance during withdrawal of the sheath from the vessel and the sheath had not kinked or been twisted/torqued prior to the separation.One non-sterile unit of a catheter sheath introducer si avanti+ 8f std w/gw no obt was received for evaluation.During visual inspection, it was noted the hemostasis valve/hub was not returned with the rest of the device.Dimensional analysis was performed to compare the returned luer hub ring outer diameter and found within specification.A highly magnified evaluation was conducted on the surface of the luer hub ring to identify any type of anomaly.During this analysis no degradation or malformation was noted that could be an attributable cause of the described event.The reported ¿hemostasis valve/hub- separated¿ was confirmed as the proximal portion of the valve was not retuned.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, ¿insert the vessel dilator through the csi¿s hemostasis valve, snapping it into place at the hub.Flush with heparinized saline or suitable isotonic solution.Thread the csi/dilator assembly over the guidewire, grasping the sheath close to the skin to prevent buckling.Using a rotating motion, advance the assembly through the tissue and into the vessel.Detach the vessel dilator from the csi by releasing the snap-fit ring at the hub.Withdraw the guidewire and dilator.Introduce the selected catheter into the csi using one of the following methods: a.Straighten the catheter tip by hand.B.Insert a guidewire into the catheter until the tip is straight.Note: hold the sheath in place when inserting, positioning, or removing the catheter.The suture collar may be used as a temporary suture site.¿ based on the available information, there is no indication that 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, 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: 19153125
• Report Number: 9616099-2024-00118
• Device Sequence Number: 12873033
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)270131(10)18283823
• 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,Followup
• Report Date (Section B): 08/26/2024

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: 504608X
• Device Lot Number: 18283823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 06/03/2024; 08/26/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 04/24/2024; 06/06/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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: Female