MAUDE Adverse Event Report: CORDIS CORPORATION 5F10CM SW RADIAL; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17982279 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 or Problem Description
As reported, a 5f 10cm sw transradial rain sheath was advanced over the stainless-steel wire and upon insertion of the sheath, the hydrophilic coating began to shear off.The rain sheath was fully inserted, significant amount of hydrophilic coating was evident at the tissue tract insertion site.There was no reported patient injury.The rain sheath was prepped by flushing components and dipping in the bowl of saline.The device will not be returned for evaluation as it was discarded after the case.
Additional Manufacturer Narrative
Complaint conclusion: a 5f 10cm sw transradial rain sheath was advanced over a stainless-steel wire and upon insertion of the sheath, the hydrophilic coating began to shear off.The rain sheath was fully inserted and a significant amount of hydrophilic coating was evident at the tissue tract insertion site.The rain sheath was prepped by flushing components and dipping in a bowl of saline.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17982279 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿coating-sheaths-separated¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as operator technique, may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿users are instructed to inspect the product and package for any damage prior to use.¿remove the product from the packaging tray with care to avoid damage to the sheath.If resistance is felt upon insertion or withdrawal, investigate the cause before continuing.¿ additionally, per the ifu, ¿soak the csi in sterile heparinized saline or similar isotonic solution to activate the hydrophilic coating.If using a hydrophilic access wire, soak the wire as well to activate the coating.¿ it is difficult to draw a clinical conclusion between the device and the event based on the information available.It is probable that handling factors such as the user¿s interaction (technique) with the device during prep and improper activation of the hydrophilic coating during the soaking step may have led to the reported events.Neither the phr review nor the information available suggest that the reported event is related to the manufacturing process of the unit; therefore, no corrective/preventative actions have been taken at this time.However, a risk assessment has been initiated to further investigate this type of complaint.

• Brand Name: 5F10CM SW RADIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11937657
• Report Number: 9616099-2021-04603
• Device Sequence Number: 4227087
• Product Code: DYB
• UDI-Device Identifier: 20705032078914
• UDI-Public: 20705032078914
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 506510S
• Device Lot Number: 17982279
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKOWN