MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI + 5F STD W/GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number 504605X

Device Problems Fracture (1260); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.No product was received for analysis, instead one picture related to the reported failure was received.In the picture, the device can be observed a non-sterile unit inside the tray.The unit does not look assembled in the original position.The mini guidewire fracture cannot be noticed as part of the picture.No other anomalies on the product can be noticed at the attached picture.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, hair was found inside the sterile package of the 5f standard (std) avanti plus catheter sheath introducer (csi) with guidewire.The mini guidewire looks fractured/separated.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).The damage was noted after it had been received, and stored in the lab, prior to using.The device was stored in the lab as per the ifu.The device is expected to be returned for analysis.Image is available for review.

Manufacturer Narrative

Complaint conclusion: as reported, hair was found inside the sterile package of the 5f standard (std) avanti plus catheter sheath introducer (csi) with guidewire.The mini guidewire looks fractured/separated.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).The damage was noted after it had been received, and stored in the lab, prior to using.The device was stored in the lab as per the ifu.The product was not returned for analysis.A single photograph was provided for review.Per visual analysis, it can be observed a non-sterile unit inside the tray.The unit does not look assembled at original position.The mini guidewire fracture cannot be noticed as part of the picture.No other anomalies on the product can be noticed per analysis.A product history record (phr) review of lot 17759594 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 & mini guidewire fracture" could not be confirmed by analysis of the photograph and as the product was not returned.The exact cause of the reported event could not be conclusively determined.Procedural/handling factors, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.Note: ¿use before¿ or ¿use by¿ date prior to using product.¿ 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.

Manufacturer Narrative

Complaint conclusion: as reported, hair was found inside the sterile package of the 5f standard (std) avanti plus catheter sheath introducer (csi) with guidewire.The mini guidewire looks fractured/separated.The product was stored and handled according to the instructions for use (ifu).The damage was noted after it had been received, and stored in the lab, prior to using.The device was stored in the lab as per the ifu.There was no reported patient injury.Initially, the product was not returned for analysis.A single photograph was provided for review.Per visual analysis, it can be observed a non-sterile unit inside the tray.The unit does not look assembled at original position.The mini guidewire fracture cannot be noticed as part of the picture.No other anomalies on the product can be noticed per photo analysis.Subsequently, one non-sterile unit of a catheter sheath introducer avanti + 5f std w/gw was received.Per visual analysis, no damages or anomalies were observed on the returned device.No other analysis was performed.A product history record (phr) review of lot 17759594 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 since the packaging was not returned.The reported ¿mini guidewire- fractured-separated - prior to use¿ could not be confirmed by analysis.The exact cause of the reported event could not be conclusively determined.Procedural/handling factors, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.Note: ¿use before¿ or ¿use by¿ date prior to using product.¿ users are instructed to carefully examine packages and devices prior to use.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.

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.

• Brand Name: AVANTI + 5F STD W/GW
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11633115
• MDR Text Key: 247794914
• Report Number: 9616099-2021-04391
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 10705032009980
• UDI-Public: 10705032009980
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 504605X
• Device Catalogue Number: 504605X
• Device Lot Number: 17759594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.