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)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This is one of two products reported with this issue and the associated manufacturer report numbers are 9616099-2015-00088 and 9616099-2015-00089.Complaint conclusion: a report was received that two 5f exoseal devices were damaged when opened.When the devices were returned, the devices and their inner pouches were in a melted condition with a potential that the sterility had been compromised.The site reported that this damage was noted when the devices were removed from storage.They further reported that it was not possible for this damage to have occurred as a result of being re-shelved.The products had never been used.Two exoseal vascular closure device 5 french (ous) devices were received inside of a sealed pouch.The exoseal devices were received inside of its¿ inner package.During visual analysis it was found that the inner package and the devices presented with a melted condition.Review of the manufacturing records for these lots revealed that the devices met specification prior to their release.The product instructions for use (ifu) warns the user to not use the device if the package or any portion of the package has been previously opened or the device is damaged or defective in any way.Users are warned that the device is for single use only and should not be resterilized or reused.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure, which in turn, may result in patient injury, illness or death.The ifu further warns that the device should not be used if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred as this may lead to infection.Based on the information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.The reported ¿packaging/pouch/box / compromised sterility¿, ¿packaging/pouch/box / damaged-inner package¿ and ¿damaged-inner package / damaged-prior to use¿ events were confirmed based on the condition of the devices.A risk assessment has been initiated to further investigate this issue.

Manufacturer Narrative

Additional information was received: the devices were never stored near a heat or steam source in the hospital receiving department, or the procedural area.There was no time in which the devices were exposed to direct sunlight or an area with high humidity.The condition of the exoseal devices were found in the combined procedures department, hull radiology and x-ray.It was found in the procedural area when they were being shelved.The individual exoseal device get removed from the boxes in the receiving area.They were retained from the same exoseal box.No damage was noted to the other exoseal devices that were retained in the same box and they were used.It was not possible that the devices could they have fallen and been exposed to any heat source after they were shelved as none of the other exoseal devices from the same box were damaged or melted.Complaint conclusion updated due to new information: a report was received that two 5f exoseal devices were damaged when opened.When the devices were returned, the devices and their inner pouches were in a melted condition with a potential that the sterility had been compromised.The site reported that this damage was noted when the devices were removed from storage.Further investigation of the site¿s handling of these products revealed that the individual exoseal devices were removed from their boxes when in the hospital receiving area.These devices were then taken to the procedural department and shelved in the procedural storage area.The damage reported by the site was noted when they were shelving them in the storage area.The site reported that the two exoseal devices were from the same box and that they were the only ones from this box with this damage.The remaining devices were successfully used by the site.The site further reported that the devices were never stored near a heat and/or steam source and had never been exposed to direct sunlight or high humidity.The site reported that it was not possible for the devices to have fallen, been exposed to heat or humidity and then re-shelved.The damaged devices had not been used, opened, re-sterilized or re-shelved at any time.Two exoseal vascular closure device 5 french (ous) devices were received inside of a sealed pouch.The exoseal devices were received inside of its¿ inner package.During visual analysis it was found that the inner package and the devices presented with a melted condition.Review of the manufacturing records for these lots revealed that the devices met specification prior to their release.The product instructions for use (ifu) warns the user to not use the device if the package or any portion of the package has been previously opened or the device is damaged or defective in any way.Users are warned that the device is for single use only and should not be resterilized or reused.Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure, which in turn, may result in patient injury, illness or death.The ifu further warns that the device should not be used if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred as this may lead to infection.Based on the information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.The reported ¿packaging/pouch/box / compromised sterility¿, ¿packaging/pouch/box / damaged-inner package¿ and ¿damaged-inner package / damaged-prior to use¿ events were confirmed based on the condition of the devices.A risk assessment has been initiated to further investigate this issue.This is one of two products reported with this issue and the associated manufacturer report numbers are 9616099-2015-00088 and 9616099-2015-00089.

Event Description

As reported, the exoseal was damaged when opened (damage includes packaging).Event date is unknown.It was reported that both exoseal device and the inner pouches were ¿melted.¿ it was reported that it is unknown if the sterility of the exoseal devices were compromised due to the damages reported.However, after review of the pictures provided by the decontamination site of the devices, it is believed that the sterility of the packaging was compromised.This issue was noted upon removal from storage, before attempting to use for a procedure.It is not possible that this occurred due to anticipation of use before being reshelved.The products were never used.

Manufacturer Narrative

The device has been received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.Please note that there was no patient involvement, therefore, the gender has been populated as unknown.Please note that the event date is unknown.This is one of two products reported with this issue and the associated manufacturer report numbers are 9616099-2015-00088 and 9616099-2015-00089.

• 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: 4551629
• MDR Text Key: 13104603
• Report Number: 9616099-2015-00088
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2015

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 Expiration Date: 06/30/2016
• Device Catalogue Number: EX500CE
• Device Lot Number: 17061227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/20/2015; 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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: ANOTHER EXOSEAL DEVICE OF THE SAME LOT.