MAUDE Adverse Event Report: CORDIS US CORP EXOSEAL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number EX600

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

As reported, when the package of a 6f exoseal vascular closure device (vcd) was opened, it was found that the plug at the tip of the device had obvious dislodgement and the tip of delivery sheath was cracked.There was no reported patient injury.The vcd was used in a diagnostic procedure using an antegrade approach.The physician had achieved certification on the use of exoseal vcd.There were no visible signs of device or package damage prior to use.The medical staff immediately stopped using it.The device was used with a 6f non-cordis sheath.The device was stored and prepped per the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.The puncture site did not have visible calcium or plaque.There was no access vessel tortuosity.There was no stent near the puncture site.The vessel did not have stenosis >50% at or near the puncture site.The target femoral site was not previously closed with any closure device or manual compression less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to exoseal vcd use.Hemostasis was achieved by manual compression.The device is being returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, when the package of a 6f exoseal vascular closure device (vcd) was opened, it was found that the plug at the tip of the device had obvious dislodgement and the tip of delivery sheath was cracked.There was no reported patient injury.The vcd was used in a diagnostic procedure using an antegrade approach.The physician had achieved certification on the use of exoseal vcd.There were no visible signs of device or package damage prior to use.The medical staff immediately stopped using it.The device was used with a 6f non-cordis sheath.The device was stored and prepped per the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.The puncture site did not have visible calcium or plaque.There was no access vessel tortuosity.There was no stent near the puncture site.The vessel did not have stenosis >50% at or near the puncture site.The target femoral site was not previously closed with any closure device or manual compression less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to exoseal vcd use.Hemostasis was achieved by manual compression.One non-sterile vascular closure device 6f was received for analysis.Per visual analysis, the deployment lever on the device was not depressed and the plug was present in the delivery shaft in its manufactured position, which was found with dry blood residues.The indicator wire was not deployed, the indicator window was received in the white/black position, and the guard was found unlocked.Additionally, the delivery shaft had a kinked section, located approximately 12.6 cm and 14.6 from the distal tip.No other anomalies were observed during the analysis.Dimensional analysis was performed to verify the correct catheter distal tip inner diameter (id) and the correct delivery shaft outer diameter (od); and the od/id measurements were taken near the kinked sections on the delivery shaft.Dimensional analysis results was found within specification for the id and od.A functional analysis was performed on the returned device.The cowling guard was depressed to deploy the indicator wire; then the indicator wire was pulled to move the indicator window from the black/white state as received into the black/black state.At the black/black stage, a cut was made before the plug to release pressure due to the dry blood residues, then the deployment button was pushed down.There was no friction noted, and it was completely depressed.Also, the indicator window turned into black/red/white state as expected.The three stages were achieved in the indicator window as expected and the deployment button performed properly.Per microscopic analysis, the device case was opened, and the internal mechanism was inspected with a vision system to magnify the image.The internal mechanism was assembled correctly, and no anomalies were observed.In addition, the delivery shaft was observed to be severely kinked/bent as received; however, no cracks were note on it.The reported event of ¿vascular closure device (vcd)-deployment difficulty-premature deployment¿ was not confirmed through analysis the returned device since the plug was still in its manufactured position and it passed functional analysis.Also, the reported event of ¿delivery shaft-cracked¿ was not confirmed through analysis of the returned device since there were no cracks noted; however, the shaft was noted to be severely kinked/bent.The exact cause of the issue experienced by the customer and the returned condition could not be conclusively determined during analysis.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the issue noted when opening the package, especially since the reported issues could not be confirmed during product analysis.However, as there were dry blood residues noted to the plug, it is possible that the returned device was attempted to be used in the procedure; therefore, handling factors (such as during insertion into the procedural sheath) could have contributed to kinked/bent conditions noted.According to the instructions for use (ifu), which is not intended as a mitigation, it warns ¿do not use the exoseal vcd if the device appears damaged or defective in any way.¿ the ifu also states, ¿remove the exoseal vcd from the sterile packaging using aseptic technique.Examine the device for any damage.Verify the presence of all components.Hold the exoseal vcd in the right hand and position the left hand on the patient at the insertion site holding the vascular sheath introducer hub.Using the left hand¿s thumb and index finger insert the distal end of the delivery shaft into the vascular sheath introducer while continuing to hold the vascular sheath introducer hub using the right hand to support and guide the exoseal vcd.¿ neither the product analysis, nor the information available for review suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: EXOSEAL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• 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: 18465311
• MDR Text Key: 332987989
• Report Number: 9616099-2024-00008
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: 10705032058858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: EX600
• Device Lot Number: 18176399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KDL 6F SHEATH.