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

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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter telephone number (b)(6).A review of the manufacturing documentation associated with lot 18062289 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.
Event or Problem Description
As reported, after "several usings" a 7f avanti+ catheter sheath introducer separated into 2 pieces inside the patient, and a long time was spent trying to remove the sheath.There was no reported patient injury.Additional information was requested but is unavailable at this time.The device is being returned for evaluation.
Additional Manufacturer Narrative
As reported, after "several usings" a 7f avanti+ catheter sheath introducer (csi) separated into 2 pieces inside the patient, and a long time was spent trying to remove the sheath.There was no reported patient injury.A non-sterile ¿si avanti+ 7f std w/gw no obt¿ was received for evaluation.The csi was the only component returned for analysis.The unit presented with a separation to the cannula, which is located approximately 3.5 cm from the proximal end.The separated piece was not returned for analysis.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The separated area was inspected with a vision system and presented evidence of elongations and a scratch mark near the ruptured area.A product history record (phr) review of lot 18062289 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as ¿catheter sheath introducer (csi)- separated" was confirmed because the returned unit presented with a separation on the cannula.The exact cause for the observed damage could not be conclusive determined.The elongations found on the material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the device was induced to a tensile force that exceeded the material yield strength prior to the rupture.Additionally, the scratch marks near the ruptured area suggest the unit was damaged with a sharp object.These findings suggest the event may have been caused by pulling on the device with a medical instrument such as a hemostat.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, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and withdraw the csi.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.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: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 16796895
• Report Number: 9616099-2023-06473
• Device Sequence Number: 16928816
• Product Code: DRE
• UDI-Device Identifier: 10705032010108
• UDI-Public: (01)10705032010108(17)240930(10)18062289
• 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
• Report Date (Section B): 06/28/2023

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: 09/30/2024
• Device Model Number: 504607X
• Device Catalogue Number: 504607X
• Device Lot Number: 18062289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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