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

Catalog Number 67000400

Device Problem Leak/Splash (1354)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

As reported, the 6f 100 cm judkins left (jl) vista brite tip guiding catheter was not connected at the proximal handle, leaking contrast.There was no reported patient injury.The lesion was mildly calcified with no vessel tortuosity and eighty percent (80%) stenosis.There were no anomalies noted when the device was taken out of the package.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device which was inspected and flushed prior to use although a continuous flush was not maintained throughout the procedure.There were no difficulties encountered while inserting or withdrawing any concomitant devices nor excessive force used during the procedure.The device is expected to be returned for evaluation.

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the 6f 100 cm judkins left (jl) vista brite tip guiding catheter was not connected at the proximal handle and leaking contrast.There was no reported patient injury.The lesion was mildly calcified with no vessel tortuosity and eighty percent (80%) stenosis.There were no anomalies noted when the device was taken out of the package.The product was stored, handled, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device which was inspected and flushed prior to use.A continuous flush was not maintained throughout the procedure.There were no difficulties encountered while inserting or withdrawing any concomitant devices nor excessive force used during the procedure.A non-sterile catheter ¿6f.070 jl4 100cm¿ was received for analysis.The unit was thoroughly inspected focusing on the luer hub.Several kinks were noted approximately 25, 56, and 69 cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis was performed by attaching a syringe filled with water to the luer hub of the catheter.The distal tip was clamped to prevent water from flowing out.Next, positive pressure was applied to check for leaks and a leak was observed on the luer hub.Sem analysis was not performed because the damages associated with the crack are visible with the magnification obtained with a vision system.The cracked area on the hub presented evidence of plastic deformation and fatigue striations.The reported ¿luer hub~leakage¿ and ¿luer hub~ cracked¿ were confirmed.The returned unit presented with a cracked condition on the luer hub, which caused the leak.Additionally, several kinks were observed on the device.The exact cause of the damages could not be conclusively determined during the analysis.However, plastic deformation and fatigue striations are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the hub was induced to a tensile force that exceeded the hub material yield strength prior to cracking.Procedural/handling factors 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, ¿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 preventive or corrective actions will be taken at this time.

Manufacturer Narrative

The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: VISTA BRITE TIP
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18816194
• MDR Text Key: 336878721
• Report Number: 9616099-2024-00067
• Device Sequence Number: 1
• Product Code: DQO
• 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: 04/30/2024

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: 67000400
• Device Lot Number: 18149815
• 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: 02/06/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/06/2024; 04/25/2024
• Supplement Dates FDA Received: 03/07/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2022
• 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
• Treatment: APT SHEATH.
• Patient Age: 57 YR
• Patient Sex: Male