MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI; DEVICE, HEMOSTASIS, VASCULAR

Model Number	504607X
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	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18184858 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there was tearing of the 7f avanti catheter sheath introducer (csi) when removing it at the end of the procedure.There was extraction of the distal piece subcutaneously.This caused extension of the duration of the procedure and the doses of radiation.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, and h6 as reported, there was tearing of the 7f avanti catheter sheath introducer (csi) when removing it at the end of the procedure.There was extraction of the distal piece subcutaneously.This caused an increase in the duration of the procedure and the dose of radiation.The product was not returned for analysis.A product history record (phr) review of lot 18184858 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter sheath introducer (csi)-separated¿ could not be confirmed.Handling factors such as withdrawing the device against resistance 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, ¿do not use if package is open or damaged.Remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.¿ based on the information available and the phr review, 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
The device was returned for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, there was tearing of the 7f avanti catheter sheath introducer (csi) when removing it at the end of the procedure.There was extraction of the distal piece subcutaneously.This caused extension of the duration of the procedure and the increased dose of radiation.A non-sterile unit of ¿si avanti+ 7f std w/gw no obt¿ was received for evaluation.During visual inspection, it was noted the cannula was separated 3 cm from the hub.The rest of the cannula was not returned.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.Vision system analysis of the ruptured area presented evidence of elongations.A product history record (phr) review of lot 18184858 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter sheath introducer-separated" was confirmed.The returned unit presented with a separation on the cannula.The exact cause of the observed damages could not be conclusive determined.However, the elongations found on the material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed the device was induced to a tensile force that exceeded the material yield strength prior to the rupture.Withdrawing the device against resistance is a possible underlying cause.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, ¿store in a dry, dark, cool place.Do not use if package is open or damaged.Remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.¿ based on the information available and the phr review, 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.

• Brand Name: AVANTI
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 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: 17287013
• Report Number: 9616099-2023-06546
• Device Sequence Number: 5523434
• Product Code: MGB
• UDI-Device Identifier: 10705032010108
• UDI-Public: (01)10705032010108(17)260131(10)18184858
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 01/31/2026
• Device Model Number: 504607X
• Device Catalogue Number: 504607X
• Device Lot Number: 18184858
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 09/01/2023; 12/27/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/25/2023; 09/28/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic