MAUDE Adverse Event Report: CORDIS CORPORATION 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)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the entire hub of a 5f 11cm avanti plus catheter sheath introducer (csi) snapped off the cannula of the sheath while being used for insertion in the femoral artery.A new 5f avanti plus csi was used as a replacement.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu).There was no difficulty experienced during the insertion process.The device will be returned for evaluation.Addendum: the dilator for the 5f 11cm avanti plus csi was returned with a separated hub.
Additional Manufacturer Narrative
The event date is unknown.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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11 complaint conclusion: as reported, the entire hub of a 5f 11cm avanti plus catheter sheath introducer (csi) snapped off the cannula of the sheath while being used for insertion in the femoral artery.A new 5f avanti plus csi was used as a replacement.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu).There was no difficulty experienced during the insertion process.The device will be returned for evaluation.A non-sterile unit of a catheter sheath introducer (avanti + 5f std w/gw) was received for analysis.On a clear plastic bag.A 5f vessel dilator was the only returned component.During visual inspection, the vessel dilator was noted to be separated into 2 pieces.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A high magnification analysis was performed on the separation borders of the vessel dilator.During this analysis, scratch marks and elongation patterns were observed near the separation borders.The conditions observed near the separation borders led this investigation to conclude that the units suffered an overloading tensile strength exposure as well as an interaction with a sharp-edged material.The reported ¿hemostasis valve/hub - separated¿ was not confirmed.However, the malfunction ¿vessel dilator ~ separated¿ was confirmed by product evaluation.The exact cause of the reported event cannot be determined.The analysis findings suggest the device was to an overloading force and an interaction with a sharp object.Therefore, 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 another isotonic solution.Introduce the needle into the vessel using an aseptic technique.Holding the needle in place, insert the flexible end of the guidewire through the needle and into the vessel.Gently advance the guidewire to the desired depth.Note: do not withdraw the guidewire back through the metal cannula of the needle after it has been inserted as it may damage the guidewire.Holding the guidewire in place, withdraw the needle and apply pressure to the puncture site until the csi is inserted into the vasculature.Thread the csi/vessel 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.To avoid damage to the csi tip, do not withdraw the vessel dilator while advancing and positioning the csi in the vessel.Detach the vessel dilator from the csi by releasing the snap fit ring at the hub.Withdraw the guidewire and vessel dilator.¿ 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 CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19632735
• Report Number: 9616099-2024-00215
• Device Sequence Number: 15651917
• Product Code: DRE
• UDI-Device Identifier: 10705032009980
• UDI-Public: (01)10705032009980(17)250831(10)18147242
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 504605X
• Device Lot Number: 18147242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 08/28/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/18/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHEATH
• Patient Sex: Unknown