MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model 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	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18151042 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the hemostasis valve of an 8f with mini-guidewire avanti+ catheter sheath introducer (csi) separated during the retrieval of the dilator.Air embolization and blood back flow through from the damaged valve was prevented by finger occlusion of the opening.The procedure has been completed with another unknown vascular access without any other complication.The introducer was then removed, and hemostasis obtained by direct compression.There was no report patient injury.The device was stored, handled, and prepped per the instructions for use (ifu).There were no anomalies noted when removed from the package.The device was placed in the jugular vein to carry out an interventional procedure for a transcatheter ablation of an atrial fibrillation.The access vessel was not calcified nor tortuous.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the hemostasis valve of an 8f with mini-guidewire avanti+ catheter sheath introducer (csi) separated during the retrieval of the dilator.Air embolization and blood back flow through from the damaged valve was prevented by finger occlusion of the opening.The procedure has been completed with another unknown vascular access without any other complication.The introducer was then removed, and hemostasis obtained by direct compression.There was no report patient injury.The device was stored, handled, and prepped per the instructions for use (ifu).There were no anomalies noted when removed from the package.The device was placed in the jugular vein to carry out an interventional procedure for a transcatheter ablation of an atrial fibrillation.The access vessel was not calcified nor tortuous.One non-sterile si avanti+ 8f std w/gw no obt unit was received for analysis.Coiled inside a plastic bag.The device was unpacked to proceed with the product evaluation.During visual inspection, the vessel dilator was received inserted on the sheath introducer.The brim cap and the hemostasis valve were attached to the device.No separation or damages were observed however, the brim cap was observed partially assembled.Microscopic analysis was performed and a damaged ring on the hub was found.A product history record (phr) review of lot 18151042 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event ¿hemostasis valve/hub¿ separated¿ was confirmed since during visual and microscopical analysis a partially assembled brim cap and a damaged ring on the hub was found.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.Remove air from csi by flushing with heparinized saline or suitable isotonic solution.¿ the product history record review does not suggest that the event experienced by the customer could be related to the manufacturing process however, a risk assessment has already been initiated.No further actions will be taken at this time.

• 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 ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16538994
• Report Number: 9616099-2023-06332
• Device Sequence Number: 6490526
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)250831(10)18151042
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 08/31/2025
• Device Model Number: 504608X
• Device Catalogue Number: 504608X
• Device Lot Number: 18151042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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 VASCULAR ACCESS; UNKNOWN VASCULAR ACCESS
• Patient Age: 70 YR
• Patient Sex: Female