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

Catalog Number EX700

Device Problem Premature Activation (1484)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

As reported, the indicator window of a 7f exoseal vascular closure device (vcd) never changed during the operation of the closure device.After removal of the device from the patient the indicator wire loop was not deployed.The surgeon depress the button just before the device was about to exit the body surface.The indicator window was in the black/white stage when the surgeon depressed the button.There was no reported patient injury.There were no visible signs of device/package damage prior to use.There was pulsatile flow observed from the bleed-back indicator.The exoseal vcd and 8f cordis vascular sheath introducer were retracted together until bleed back significantly slowed or stopped.The indicator window did not show any red color during retraction.When the device was removed from the patient, the indicator wire loop was not deployed/showing.An 8f cordis short sheath was used.The target femoral site was not previously closed with any closure device or manual compression less than thirty days prior to this procedure.There was no stent near the puncture site.The vessel did not have stenosis >50% at or near the puncture site.The exoseal vcd was used in an interventional procedure with an retrograde approach.The physician had achieved certification on the use of exoseal vcd.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be 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.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, the indicator window of a 7f exoseal vascular closure device (vcd) never changed during the operation of the closure device.After removal of the device from the patient the indicator wire loop was not deployed.The surgeon depressed the button just before the device was about to exit the body surface.The indicator window was in the black/white stage when the surgeon depressed the button.There was no reported patient injury.There were no visible signs of device/package damage prior to use.There was pulsatile flow observed from the bleed-back indicator.The exoseal vcd and 8f cordis vascular sheath introducer were retracted together until bleed back significantly slowed or stopped.The indicator window did not show any red color during retraction.When the device was removed from the patient, the indicator wire loop was not deployed/showing.An 8f cordis short sheath was used.The target femoral site was not previously closed with any closure device or manual compression less than thirty days prior to this procedure.There was no stent near the puncture site.The vessel did not have stenosis >50% at or near the puncture site.The exoseal vcd was used in an interventional procedure with a retrograde approach.The physician had achieved certification on the use of exoseal vcd.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile unit of product ¿vascular closure device 7f¿ was received for product evaluation.Per visual analysis, product evaluation found the following conditions: the deployment lever was fully depressed and the indicator window was received black/white/red color as expected; the plug is fully deployed and it was not included in the shipment; the cowling/guard was received unlocked; bleed-back port is at the deployed position; the indicator wire was retracted; and the device is blood saturated.The functional analysis was not performed since the device was received fully deployed.Per microscopic analysis, the device case was opened, and the internal mechanisms were inspected with a vision system to magnify the image.The internal mechanisms were assembled correctly, and no other anomalies were observed.The reported events of ¿indicator window-no change to indicator¿ and ¿deployment lever (button)-inaccurate deployment-at white/black position¿ were not confirmed through analysis of the returned device since the product was received fully deployed and there were no anomalies noted to the internal mechanisms.The exact cause of the issues experienced by the customer could not be conclusively determined during analysis.Based on the information available for review and the product analysis, it is not possible to determine what factors may have contributed to the reported no change to indicator and deploying the button at the white/black position of the indicator window since the window was received in the black/white/red position as expected for a fully deployed device and there were no anomalies noted to the internal mechanisms during microscopic analysis.However, procedural/handling factors are possible.As warned in the instructions for use (ifu), which is not intended as a mitigation, ¿do not use the exoseal¿ vcd if the device appears damaged or defective in any way.¿ the ifu also cautions, ¿the exoseal¿ vascular closure device procedure should be performed by physicians who have expertise in the techniques of vascular catheterization (or other healthcare professionals authorized by, or under the direction of, such physicians) and possess adequate training in the use of the device, e.G.Participation in an exoseal¿ closure device training program.¿ additionally, the ifu states, ¿while holding the exoseal¿ vcd in the right hand, making sure the thumb is not placed on the plug deployment button, continue retracting the exoseal¿ vcd and vascular sheath introducer very slowly (controlling retraction with the left hand) until the graphic pattern in the indicator window changes to a solid black color, at which point the plug is correctly positioned for deployment.Caution: if the graphic pattern in the indicator window does not change to a solid black color after approximately 1 cm of retraction from the point pulsatile flow significantly slowed or stopped, discontinue the use of the device.¿ additionally, it was reported that an 8f sheath was used with the 7f exoseal vcd during the procedure.As reported in the product description within the ifu, ¿note: the indwelling vascular sheath introducer must allow the bleed-back port to extend beyond the distal tip of the sheath.The french size of the exoseal¿ vcd must correspond to the french size of the vascular sheath introducer in use.¿ usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.Neither the product analysis, nor the information available for review suggest that the reported issues 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: 18405421
• MDR Text Key: 332496279
• Report Number: 9616099-2023-06676
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10705032058896
• UDI-Public: 10705032058896
• 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: 01/23/2024

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: EX700
• Device Lot Number: 18177837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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: 8F CORDIS SHORT SHEATH