MAUDE Adverse Event Report: CORDIS US. CORP RAIN SHEATH TRANSRADIAL; INTRODUCER, CATHETER

Catalog Number	506510N
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the 5f 10cm trans-radial rain sheath kept kinking on the end and in the center.There were no reports of patient injury.The device was opened in a sterile field and was used in patient.The product was stored as per labeling.The device will be returned for evaluation.Addendum: per pe findings, the cannula of the catheter sheath introducer (csi) presents an accordioned condition located approximately on 8 cm from the distal tip.Also, the cannula presents a frayed condition on the distal tip.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the 5f 10cm trans-radial rain sheath kept kinking on the end and in the center.There were no reports of patient injury.The device was opened in a sterile field and was used in the patient.The product was stored as per labeling.A non-sterile ¿5f10cm nw radial¿ was received for analysis.The vessel dilator and the csi were returned and the vessel dilator was fully inserted into the cannula.The cannula of the csi presented with an accordioned condition located approximately 8 cm from the distal tip.Additionally, the cannula presented with a frayed condition on the distal tip.No damages were observed on the vessel dilator.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Sem analysis was not performed because the damages associated with the frayed condition of the distal tip are visible with the magnification obtained with a vision system.The distal tip was inspected with a vision system to obtain a magnified image of the damage.The unit presented evidence of scratch marks, elongations, and plastic deformation.The failure reported by the customer as ¿catheter sheath introducer (csi)~kinked/bent¿ was not confirmed, no kinked condition was observed on the returned device.The failures reported by the customer as ¿catheter sheath introducer (csi)~ accordioned¿ and ¿brite tip/distal tip~ frayed/split/torn ¿were confirmed.An accordioned condition and a distal tip- frayed condition was observed on the cannula.The scratch marks, elongations and plastic deformation found on the device are commonly caused during the interaction of the material with an unknown sharp object causing mechanical damage.Therefore, it is assumed that the distal tip was induced to a force that exceeded the material yield strength prior to the fraying.Procedural and/or handling factors likely contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if the device becomes kinked or increased resistance is felt upon insertion or advancement of the vessel dilator, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the vessel dilator.If increased resistance is felt upon withdrawal of the vessel dilator, investigate the cause before continuing, as excessive force during vessel dilator withdrawal can cause product damage or vascular complications.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: RAIN SHEATH TRANSRADIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US. CORP; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19685995
• Report Number: 9616099-2024-00226
• Device Sequence Number: 6965041
• Product Code: DYB
• UDI-Device Identifier: 10705032082150
• UDI-Public: (01)10705032082150(17)250930(10)18155905
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 09/30/2025
• Device Catalogue Number: 506510N
• Device Lot Number: 18155905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/06/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown