MAUDE Adverse Event Report: CORDIS CORPORATION 6F 10CM SW RADIAL; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 506610S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17871726) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, both 5f 10cm single wall (sw) transradial sheath and 6f 10cm single wall (sw) transradial sheath was noted to have a liquid on the hemostasis valve entrance upon opening the package.There was reported patient injury.The client has never seen before a liquid from a sterilized package and asking if it is normal for a transradial sheath.The liquid was noted on both devices.Initially, the client received the trial stock and decided to do some training.The devices were not stored and handled per the instructions for use (ifu) as the devices came directly from dhl delivery truck.The seal of the inner package was not opened.The products were not purposely opened in anticipation of use.The devices were never stored in the lab.The products were not used.The devices will be returned for evaluation.

Manufacturer Narrative

One 5f 10cm single wall (sw) transradial sheath and one 6f 10cm single wall (sw) transradial sheath were noted to have a liquid on the hemostasis valve entrance upon opening the package.There was no reported patient injury.The liquid was noted on both devices.Initially, the client received the trial stock and decided to do some training.The devices were not stored and handled per the instructions for use (ifu), as the devices came directly from the delivery truck.The devices were never stored in the lab.The seal of the inner package was not opened.The products were not purposely opened in anticipation of use.The products were not used.The products were not returned for analysis.The product was not returned for analysis.A picture was submitted for review.A non-sterile csi product still inside of an open pouch was observed in the picture.On the superior area of the cap a liquid or fluid was observed.No other details of the product can be noticed at the picture.A product history record (phr) review of lot 17871726 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box - foreign material in sterile package¿ could not be confirmed as the products were not returned for analysis.The cause of the reported events could not be conclusively determined.However, the presence of lubricant which is inherent to the manufacturing process on the csi (catheter sheath introducer) units was confirmed by the attached pictures.It should be noted that the medical fluid is biocompatible, and these devices are safe to be used with the fluid.The medical fluid is intended to lubricate the interaction between the vessel dilator and the gasket component.According to the instructions for use, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ standard clinical practice calls for inspection of the device and packaging prior to use in the patient.If the user notes anything unusual, they are urged to discontinue use of the device and exchange for another.Neither the phr review nor the product analysis suggests that the reported event could be a failure or defect related the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-03343.

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.Section d10: device was not received for evaluation; however, device images were received for evaluation this is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-03343 and 9616099-2019-03344.

Manufacturer Narrative

After further review of additional information received the following sections d10, g4, g7, h2, h3 and h6 have been updated accordingly.One 5f 10cm single wall (sw) transradial sheath and one 6f 10cm single wall (sw) transradial sheath were noted to have a liquid on the hemostasis valve entrance upon opening the package.There was no reported patient injury.The liquid was noted on both devices.Initially, the client received the trial stock and decided to do some training.The devices were not stored and handled per the instructions for use (ifu), as the devices came directly from the delivery truck.The devices were never stored in the lab.The seal of the inner package was not opened.The products were not purposely opened in anticipation of use.The products were not used.The product was returned for analysis.Two non-sterile 6f 10cm sw radial along with two mini guidewires and two vessel dilators were received for analysis inside a plastic bag.Per visual analysis, an oily substance was observed on the surface of the csi valve.No other anomalies were observed.Also, two sterile units of 6f 10cm sw radial were received inside of a plastic bag.The seals of all the product packaging were intact.The integrity of the sterile pouches was not compromised.The returned units shown oily substance on the valve of the csi.No other anomalies were observed on the returned product.Per ftir analysis, that valve is made of polyethylene and the oily substance was identified as mdx fluid; since characteristic ir bands were found on the spectrum corresponding to this material.Mdx fluid is a lubricant usually applied to csi valves during manufacturing process.A product history record (phr) review of lot 17871726 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box - foreign material in sterile package¿ was not confirmed during analysis of the returned devices.The oily substance was noted to be mdx fluid during ftir analysis.It should be noted that the medical fluid is biocompatible, and these devices are safe to be used with the fluid.The medical fluid is intended to lubricate the interaction between the vessel dilator and the gasket component.According to the instructions for use, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ standard clinical practice calls for inspection of the device and packaging prior to use in the patient.If the user notes anything unusual, they are urged to discontinue use of the device and exchange for another.Neither the phr review nor the product analysis suggests that the reported event could be a failure or defect related the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2019-03343 and 9616099-2019-03344.

• Brand Name: 6F 10CM SW RADIAL
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9293651
• MDR Text Key: 199103612
• Report Number: 9616099-2019-03344
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2020

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: 05/31/2022
• Device Catalogue Number: 506610S
• Device Lot Number: 17871726
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 12/06/2019; 06/04/2020
• Supplement Dates FDA Received: 12/18/2019; 12/23/2019; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1