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

Model Number	506510S
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	04/30/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported, the hydrophilic coating of a 5f 10cm transradial rain sheath introducer came off during insertion.There was no reported patient injury.The intended procedure was a heart cath.There were no visible signs of device/package damage prior to use.There were no anomalies noted when removed from the package.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The product, or any of the other devices used with it, had not been resterilized.There were no anomalies noted prior to inserting into the patient.The access site was radial.Excess force was not used during insertion.The patient has recovered.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: the hydrophilic coating of a 5f 10cm transradial rain sheath introducer came off during insertion.The intended procedure was a heart cath.There were no visible signs of device/package damage prior to use.There were no anomalies noted when removed from the package.The device was prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The product, or any of the other devices used with it, had not been resterilized.There were no anomalies noted prior to inserting into the patient.The access site was radial.Excess force was not used during insertion.There was no reported patient injury.The patient has recovered.The product was returned for analysis.Per visual analysis, one non-sterile unit of a catheter sheath introducer (5f10cm sw radial) was received inside of a clear plastic bag.No anomalies were noted on the returned device.A microscopic or functional analysis was not performed.A product history record (phr) review of lot 17987616 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-in patient¿ could not be confirmed since no coating was observed to be separated from the sheath per visual analysis.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as operator handling or technique, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿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 insertion and improper activation of the hydrophilic coating during the soaking step may have led to the reported events.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.

• 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: 11883361
• Report Number: 9616099-2021-04582
• Device Sequence Number: 17065280
• Product Code: DYB
• UDI-Device Identifier: 10705032078917
• UDI-Public: 10705032078917
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 06/10/2021

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: 10/31/2023
• Device Model Number: 506510S
• Device Catalogue Number: 506510S
• Device Lot Number: 17987616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1