MAUDE Adverse Event Report: CORDIS CORPORATION INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 538421

Device Problems Crack (1135); Device-Device Incompatibility (2919)

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

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the hub of a 4f 100cm judkins right (jr) 4 infiniti diagnostic catheter was cracked and leaking when flushed.There were no reported injuries to the patient and the device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the hub of a 4f 100cm judkins right (jr) 4 infiniti diagnostic catheter was cracked and leaking when flushed.Additionally, the luer lock would not stay tight.There were no reported injuries to the patient.The device was not returned for evaluation.Without the return of the device or images for review, the reported ¿luer hub-cracked¿ and ¿luer hub-incompatibility/fit¿ could not be confirmed.Storage and/or handling factors such as overtightening may be a contributing factor.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, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding 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 hub of a 4f 100cm judkins right (jr) 4 infiniti diagnostic catheter was cracked and leaking when flushed.Additionally, the luer lock would not stay tight.There were no reported injuries to the patient and the device was not returned for evaluation.

Manufacturer Narrative

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

Event Description

As reported, the hub of a 4f 100cm judkins right (jr) 4 infiniti diagnostic catheter was cracked and leaking when flushed.Additionally, the luer lock would not stay tight.There were no reported injuries to the patient and the device will be returned for evaluation.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 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 ; 7863138372
• MDR Report Key: 18545618
• MDR Text Key: 333319660
• Report Number: 9616099-2024-00025
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014618
• UDI-Public: 10705032014618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

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
• Device Catalogue Number: 538421
• Device Lot Number: 18150362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 03/05/2024
• Supplement Dates FDA Received: 03/01/2024; 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2022
• 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