MAUDE Adverse Event Report: CORDIS CORPORATION 6F10CM SW RADIAL; INTRODUCER, CATHETER

Model Number 506610S

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/01/2020

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

Event Description

When a 6f 10cm sw transradial rain sheath introducer was pushed in, the hydrophilic coating was pushed together.Therefore, the sheath has been removed and continued with the non-cordis sheath.There was no reported patient injury.The user is still in training with the device.The device was opened in a sterile field.The sheath was well watered just before insertion.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: when a 6f 10cm sw transradial rain sheath introducer was pushed in, the hydrophilic coating was pushed together.Therefore, the sheath had been removed and continued with a non-cordis sheath.There was no reported patient injury.The user is still in training with the device.The device was opened in a sterile field.The sheath was well watered just before insertion.The product was returned for analysis.A non-sterile unit of ¿6f10cm sw radial¿ was received inside of a clear plastic bag.Per visual analysis, the vessel dilator was returned already inserted inside the csi cannula.The part was thoroughly inspected observing an accordioned condition located approximately at 1.8 cm from the distal tip.No delamination condition was observed.No other damages or anomalies were observed on the returned unit.Dimensional analysis results for the cannula were found within specification.The cannula was inspected using a vision system to obtain a magnified image.The accordioned condition was confirmed, and no delamination characteristics were observed.A product history record (phr) review of lot 17972089 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿coating-sheaths delaminated¿ was not confirmed during analysis of he returned device.No delamination condition was observed.However, the cannula presented with an accordioned condition.The exact cause of the reported events could not be conclusively determined.Procedural factors, such as excessive force used, may have contributed to the reported events.According to the instructions for use, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 6F10CM SW RADIAL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11099847
• MDR Text Key: 224521195
• Report Number: 9616099-2020-04165
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K984500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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: 08/31/2023
• Device Model Number: 506610S
• Device Catalogue Number: 506610S
• Device Lot Number: 17972089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MERRIT SHEATH; MERRIT SHEATH