MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ .035 F11 W/MINI GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number 402611X

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

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

No product was received for analysis, instead one picture related to the reported failure.The picture shows the non-sterile product inside the original packaging (tray).The picture was taken focusing into the cap component.No other anomalies of the product can be noticed in the picture.Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

Upon receipt, two (2) f11 0.035 11cm avanti plus transradial kit catheter sheath introducer (csi) with mini guidewire had unknown liquids near the six-page flap of the inner sheath of the short sheath in inner packing.There was no reported patient injury.There were no damaged noted to the device packages.The devices are expected to be returned for analysis.Image is available for review.No other information was provided.

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

This is one of two products involved with the reported event.The medical device reporting reference number for the other event is 9616099-2021-04385.Upon receipt, two (2) f11 0.035 11cm avanti plus transradial kit catheter sheath introducer (csi) with mini guidewire had unknown liquid near the six-page flap of the inner sheath of the short sheath in inner packing.There was no damage noted to the device packages.The devices are not expected to be returned for analysis.Image is available for review.No other information was provided.There was no reported patient injury.The devices were not returned for analysis.One photograph was provided for review.Per photograph analysis, it can be observed one non-sterile product inside the original packaging (tray).The picture was taken focusing on the cap component.No other anomalies of the product can be noticed at the attached picture.A product history record (phr) review of lot 17930533 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 devices were not returned for analysis.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as operator handling, may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿precautions: store in a dry, dark, cool place.Do not use if package is open or damaged.Use prior to the ¿use by¿ date.Exposure to temperatures above 54°c (130°f) may damage the catheter sheath and components.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: upon receipt, two (2) f11 0.035 11cm avanti plus transradial kit catheter sheath introducer (csi) with mini guidewire had unknown liquid near the six-page flap of the inner sheath of the short sheath in the inner packing.There was no damage noted to the device packages.Image is available for review.There was no reported patient injury.No other information was provided.2021-00146302-1 originally the device was not returned for analysis.One photograph was received.Per visual analysis, the non- sterile product inside the original packaging (tray) can be observed.The picture was taken focusing on the cap component.No other anomalies of the product can be noticed on the attached picture.Subsequently, one sterile si avanti+.035 f11 w/mini gw csi device was received for analysis inside a sterile package.A foreign material in the csi cap was noticed.No other anomalies were observed.The fluid was analyzed through infrared spectroscopy.Based on the analysis, the foreign material observed in the valve has polyethylene composition with mdx fluid, which is a fluid used to lubricate the device during the manufacturing process.A product history record (phr) review of lot 17930533 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 by analysis.The fluid noted is used to lubricate the device, therefore, is normal to be seen.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ additionally, users are clinically trained to inspect packages and devices prior to use for any damages and change devices when necessary.Neither the phr nor the product analysis available suggests a design or manufacturing related failure for the reported event; therefore, no corrective/preventive action will be taken at this time.2021-00146302-2 originally, the device was not returned for analysis.One photograph was received.Per visual analysis, the non- sterile product inside the original packaging (tray) can be observed.The picture was taken focusing on the cap component.No other anomalies of the product can be noticed at the attached picture.Subsequently, one sterile si avanti+.035 f11 w/mini gw csi device was received for analysis inside a sterile package.No anomalies were observed.A product history record (phr) review of lot 17930533 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 since no foreign material was observed in the package nor the device.The exact cause of the reported event could not be conclusively determined.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ additionally, users are clinically trained to inspect packages and devices prior to use for any damages and change devices when necessary.Neither the phr nor the product analysis available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SI AVANTI+ .035 F11 W/MINI GW
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11615935
• MDR Text Key: 247793256
• Report Number: 9616099-2021-04384
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032000789
• UDI-Public: 10705032000789
• Combination Product (y/n): N
• PMA/PMN Number: K970392
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 402611X
• Device Catalogue Number: 402611X
• Device Lot Number: 17930533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Date Manufacturer Received: 08/06/2021
• Patient Sequence Number: 1