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	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported after insertion of the 8f avanti sheath introducer 0.035¿x23cm into the femoral artery, the avanti sheath broke apart inside the patient.The fragments needed to be removed operatively.The puncture place was opened and all the fragments were able to be removed with a tweezer.This happened twice on the same patient; left and right femoral artery.The intended procedure was reported to be a pulmonary vein isolation (pvi).The access site was femoral.There was no calcification or tortuosity and the percentage stenosis is unknown.A contralateral approach was not used.There were no anomalies noted when the products were removed from the packaging.The products were stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the devices which were flushed prior to use.The vessel dilator snapped into placed at the hub.There was no difficulty during the insertion process.The patient was hospitalized for the pvi procedure; however, extended hospitalization was not required for this event.The devices are expected to be returned for evaluation.Two device images were provided for review.The customer wants to return the other unopened (13 units) of avanti sheaths of the same lot and is requesting a different lot.
Additional Manufacturer Narrative
A product history record (phr) review of lot 18194157 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported after insertion of the 8f avanti sheath introducer 0.035¿x23cm into the femoral artery, the avanti sheath broke apart inside the patient.The fragments needed to be removed operatively.The insertion site was opened, and all the fragments were able to be removed with a tweezer.This happened twice on the same patient; left and right femoral artery.The intended procedure was reported to be a pulmonary vein isolation (pvi).The access site was femoral.There was no calcification or tortuosity, and the percentage stenosis is unknown.A contralateral approach was not used.There were no anomalies noted when the products were removed from the packaging.The products were stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the devices which were flushed prior to use.The vessel dilator snapped into placed at the hub.There was no difficulty during the insertion process.The patient was hospitalized for the pvi procedure; however, extended hospitalization was not required for this event.2023-02628-2: a non-sterile unit of ¿csi avanti+ 8f std w/gw no obt¿ was received for evaluation.During the visual inspection, the cannula was noted to frayed/split/torn 10.5 cm from the distal tip.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 damages presented evidence of elongations.A product history record (phr) review of lot 18194157 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 not confirmed for complaint 2023-02628-2, the returned unit was not separated.However, the malfunction ¿catheter sheath introducer (csi)- frayed/split/ torn¿ was confirmed due to the damages found on the cannula.Elongations are commonly associated with damages caused by material tensile overload.Therefore, it is assumed that the devices were induced to tensile forces that exceeded the material yield strength prior to separating and tearing.Handling factors and/or patient vessel characteristics may be contributing factors.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.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 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.
Event or Problem Description
Two images were received for analysis.Image 1 shows the proximal section of an 8f csi with a fracture observed near of the hub.Rough damage was observed on the borders of the fracture area and elongation patterns could be noticed.Image 2 shows the proximal section of an 8f csi, a separation could be observed.Rough damage was observed on the borders of the separation and elongation patterns could be noticed.No other anomalies were noted during picture analysis.

• Brand Name: AVANTI
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17467141
• Report Number: 9616099-2023-06574
• Device Sequence Number: 15678961
• Product Code: DRE
• UDI-Device Identifier: 10705032010153
• UDI-Public: (01)10705032010153(17)260228(10)18194157
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: 02/28/2026
• Device Catalogue Number: 504608X
• Device Lot Number: 18194157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 08/05/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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