MAUDE Adverse Event Report: CORDIS CORPORATION EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

Catalog Number EX500CE

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, prior to use of the 5 fr.Exoseal vascular closure device (vcd) in the patient, a packaging defect/opening on the bag side was noted.Another device was used to perform the procedure.There was no reported patient injury.The product will be returned for inspection.Additional information received indicated that the product issue being reported-compromised sterility of the product.It is not known if the product received was in this condition at the account.Pictures of the reported product issue/product are not available.The product was not clinically used in a patient.It is not known if by chance the product was opened and put back into storage.Another device was used to complete the procedure after the reported product issue.The product was stored properly according to the instructions for use (ifu).No additional information is available.

Manufacturer Narrative

The product was returned for inspection on 2/4/2016.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, prior to use of the 5 fr.Exoseal vascular closure device (vcd) in the patient, a packaging defect/opening on the bag side was noted.Another device was used to perform the procedure.There was no reported patient injury.The product will be returned for inspection.Additional information received indicated that the product issue being reported-compromised sterility of the product.It is not known if the product received was in this condition at the account.Pictures of the reported product issue/product are not available.The product was not clinically used in a patient.It is not known if by any chance the product was opened and put back into storage.Another device was used to complete the procedure after the reported product issue.The product was stored properly according to the instructions for use (ifu).No additional information is available.One non-sterile exoseal vascular closure device 5 french (ous) was received inside an unknown pouch.The original pouch was not received.The unit was not deployed, the deployment lever and guard were not depressed and the indicator window was received on black/white position.No blood residues or other anomalies were found in the device.A device history record review could not be performed because the lot number was not provided.The reported event of ¿packaging/pouch/box - compromised sterility-seal open¿ was not confirmed since the device was not received with its original packaging.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.The analysis of the product does not suggest that the event reported is related to a manufacturing issue.Therefore, no corrective or preventative actions will be taken.

• Brand Name: EXOSEAL VASCULAR CLOSURE DEVICE (VCD)
• Type of Device: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5366704
• MDR Text Key: 35992075
• Report Number: 9616099-2016-00026
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2015

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: EX500CE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/12/2016; 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1