MAUDE Adverse Event Report: CORDIS US. CORP INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 534620T

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the tip of a 6f 100cm judkins left (jl) 4 infiniti diagnostic catheter appeared cut.The device was not introduced into the patient.There were no reported injuries to the patient.The device will be returned for evaluation.Addendum: received device images show the catheter is separated in two pieces.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, b5, d9, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the tip of a 6f 100cm judkins left (jl) 4 infiniti diagnostic catheter appeared cut.The device was not introduced into the patient.There were no reported injuries to the patient.The device was not returned.Four pictures were submitted for analysis.On one of the pictures the packaging is observed, an infiniti device from catalogue 534-620t, lot 18241658 could be read on the outer label.On the other photos it could be observed that the distal tip/brite tip of the unit was separated in two parts, the remaining separated part is also observed.Another catheter is observed inside the packaging, no damages are observed in the photo.The separation appears to be near the fusion point of the body-brite tip.The reported ¿catheter (body/shaft)-separated¿ was confirmed by photo analysis.The exact cause of the event cannot be determined without returning the device for analysis.Handling factors such as removing the catheter from the package by the distal tip may have 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, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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.

Event Description

As reported, the tip of a 6f 100cm judkins left (jl) 4 infiniti diagnostic catheter appeared cut.The device was not introduced into the patient.There were no reported injuries to the patient.The device was not returned as expected.Addendum: received device images show the catheter is separated in two pieces.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18721887
• MDR Text Key: 335853633
• Report Number: 9616099-2024-00056
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 534620T
• Device Lot Number: 18241658
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1