MAUDE Adverse Event Report: CORDIS CORPORATION 4F 10CM HW RADIAL; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 506410H

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17831270) 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, there was a hair in the sterile packaging of the 4f radial sheath (10cm hw radial).There was no reported patient injury.The product was stored properly according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was a hair noted when the device was taken out of the package.The integrity of the sterile pouch was compromised.The damaged was noted after it had been received, and stored in the lab, prior to using.The actual product was not damaged.The product was not used on patient.The product will be return for analysis.

Manufacturer Narrative

After further review of additional information received the following sections d10, g4, g7, h2, h3 and h6 have been updated accordingly.As reported, there was a hair in the sterile packaging of the 4f radial sheath (10cm hw radial).There was no reported patient injury.The product was stored properly according to the instructions for use (ifu).There were no visible signs of device/package damage prior to use.There was a hair noted when the device was taken out of the package.The integrity of the sterile pouch was compromised.The damaged was noted after it had been received, and stored in the lab, prior to using.The actual product was not damaged.The product was not used on patient.A non-sterile unit of ¿4f 10cm hw radial" was received inside of a clear plastic bag, along with two unknown devices.The components returned were the csi and the vessel dilator.Neither the hair nor the original packing were returned for analysis.No damages or anomalies were observed on the csi or on the vessel dilator.A product history record (phr) review of lot 17831270 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported ¿packaging/pouch/box foreign material in sterile package¿ was not confirmed through analysis of the returned device due to the condition in which it was received.The exact cause of the issue experienced could not be determined.Based on the information available for review and the product analysis, it is not possible to determine what factors may have contributed to the hair found in the sterile packaging since neither hair nor original packaging was returned for analysis.As cautioned in the instructions for use (ifu), which is not intended as a mitigation, ¿do not use if package is open or damaged.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 4F 10CM HW 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: 8838979
• MDR Text Key: 152669988
• Report Number: 9616099-2019-03101
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 506410H
• Device Lot Number: 17831270
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1