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	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, an 8f 11cm avanti plus catheter sheath introducer (csi) separated when it was being withdrawn from the patient and the separated segment remained in the patient.Two additional venous access sites were obtained to remove the separated csi segment.The device will not be returned for evaluation.
Event or Problem Description
As reported, while attempting to exchange an 8f 11cm avanti plus catheter sheath introducer (csi) over an unknown guidewire, the distal tip of the cannula separated when it was being withdrawn from the patient.The separated segment remained in the patient.Two additional venous access sites were obtained in attempt to remove the separated csi segment.However, the separated segment had to be surgically removed.The device was stored and prepped per the instructions for use (ifu).The access vessel had moderate calcification and mild tortuosity.There were no difficulties during the insertion process.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, while attempting to exchange an 8f 11cm avanti plus catheter sheath introducer (csi) over an unknown guidewire, the distal tip of the cannula separated when it was being withdrawn from the patient.The separated segment remained in the patient.Two additional venous access sites were obtained in attempt to remove the separated csi segment.However, the separated segment had to be surgically removed.The device was stored and prepped per the instructions for use (ifu).The access vessel had moderate calcification and mild tortuosity.There were no difficulties during the insertion process.The device was not returned for evaluation.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip-separated¿ could not be confirmed.Procedural/handling factors such as inserting or 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, ¿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.Insertion procedure.Remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.Discard the sheath appropriately.¿ 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 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: 19200826
• Report Number: 9616099-2024-00128
• Device Sequence Number: 7927854
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)261031(10)18259287
• 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
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 504608X
• Device Lot Number: 18259287
• Was Device Available for Evaluation?: No
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 08/26/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/22/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White