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

Model Number EX600

Device Problem Defective Component (2292)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18169749 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 Description

As reported, the device inner packaging of a 6f exoseal vascular closure device (vcd) was found porous which affected sterility.There was no reported patient injury.It was not used in the procedure.The device is being returned for evaluation.

Manufacturer Narrative

As reported, the device inner packaging of a 6f exoseal vascular closure device (vcd) was found porous which affected sterility.There was no reported patient injury.It was not used in the procedure.A non-sterile unit of product ¿vascular closure device 6f¿ was received for investigation.Per visual analysis, the unit was unused and the following conditions were found: the cowling guard was not depressed, and indicator wire was not deployed (as expected), the deployment lever was not depressed, the plug was not deployed, and indicator window was at black/white position.The unit was not returned in or with its original packaging and no blood residues were found.No additional anomalies were found.A product history record (phr) review of lot 18169749 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event of ¿packaging/pouch/box-compromised sterility-sterile barrier breached¿ could not be confirmed as the product¿s packaging was not returned for analysis.The exact cause of the reported event could not be conclusively determined during analysis of the returned device.Without the return of the product¿s packaging, and based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported event.As warned within the instructions for use (ifu), which is not intended as a mitigation of risk, ¿do not use the exoseal vcd if the package is damaged or any portion of the package has been previously opened.Do not use the exoseal vcd if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred; a broken sterile field may result in infection.¿ neither the phr review nor the analysis of the returned device suggest that the reported event could be related to the design/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 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: 17349699
• MDR Text Key: 320162244
• Report Number: 9616099-2023-06553
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10705032058858
• UDI-Public: (01)10705032058858(17)241130(10)18169749
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX600
• Device Catalogue Number: EX600
• Device Lot Number: 18169749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG