MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ TRANSRAD KIT 11CM; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

When an 11cm avanti plus transradial sheath introducer kit was opened, a hair was noticed to be present in the package.There was no reported patient injury.There was no damage to any of the packaging reported.It was after it had been received and stored in the lab, prior to using.It was stored as usual in a cabinet.The device will not be returned for evaluation.

Manufacturer Narrative

As reported, when an 11cm avanti plus transradial sheath introducer kit was opened, a hair was noticed to be present in the package.There was no reported patient injury.There was no damage to any of the packaging reported.It was after it had been received and stored in the lab, prior to using.It was stored as usual in a cabinet.The product was not returned for analysis.A product history record (phr) review of lot 17941656 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿foreign material - in sterile package¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Based on the information provided, it is impossible to determine what factors may have contributed to the reported event.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, the product analysis suggest that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SI AVANTI+ TRANSRAD KIT 11CM
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10726544
• MDR Text Key: 212969603
• Report Number: 9616099-2020-04004
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 20705032010280
• UDI-Public: 20705032010280
• 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
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 504616Z
• Device Lot Number: 17941656
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1