MAUDE Adverse Event Report: CORDIS US CORP. VISTA BRITE TIP; CATHETER, PERCUTANEOUS

Catalog Number 67005200

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, there was a leak at the screw connection of a 6f.070in x 100cm extra-back up (xb) vista brite tip guiding catheter.There were no reports of patient injury.The issue on the device was observed before being used on the patient therefore, the device was not pulled from the packaging by the hub, nor was it torqued or ¿steered¿ by the hub.There was no excessive force used.The device was stored and prepped in accordance with the instructions for use (ifu).The device will be returned for evaluation.

Manufacturer Narrative

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.

Manufacturer Narrative

Complaint conclusion: as reported, there was a leak at the screw connection of a 6f.070in x 100cm extra-back up (xb) vista brite tip guiding catheter.There were no reports of patient injury.The issue on the device was observed before being used on the patient.The device was not pulled from the packaging by the hub, nor was it torqued or ¿steered¿ by the hub.There was no excessive force used.The device was stored and prepped in accordance with the instructions for use (ifu).One non-sterile ¿6f.070 xb 3 100cm¿ unit was received for analysis.During visual inspection, no apparent damages or cracks were observed on the hub or body of the catheter.The catheter was flushed during functional analysis and results revealed a leak in the hub of the returned device.For microscopic analysis, amplified images of the hub and distal tip were taken with the vision system.The distal tip of the catheter was observed complete.However, a crack was observed on the top of the hub and prolongation of the crack was observed along the body of the luer hub.Sem analysis presented evidence of plastic deformation such as elongation and fatigue striation patterns.Additionally, scratch marks were noted around the affected area.The reported ¿luer hub-leakage" was confirmed.The malfunction ¿luer hub-cracked¿ was also confirmed.The fatigue striation patterns noted along the cracks are commonly associated with damages caused when resistance properties are overloaded.Additionally, the presence of scratch marks suggests the crack may have been caused by an interaction between the hub and a material with a sharp edge.Storage or handling factors that placed excessive stress on the device may have caused the damages.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¿ 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.

• Brand Name: VISTA BRITE TIP
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18318375
• MDR Text Key: 330381319
• Report Number: 9616099-2023-06661
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

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 Operator: Health Professional
• Device Catalogue Number: 67005200
• Device Lot Number: 18234341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/13/2023; 03/01/2024
• Supplement Dates FDA Received: 01/12/2024; 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• 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