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

Catalog Number 67000200

Device Problem Crack (1135)

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

Event Date 03/09/2024

Event Type  malfunction  

Event Description

As reported, the hub of a 6f.070 jl3.5 100cm guiding catheter is cracked and blood drips.There was no reported patient injury.The device was stored and prepped according to the ifu.There was no device or package damage noted prior to use.The device was pulled from the packaging and was handled as recommended by the ifu.The device was not torqued or steered by the hub.There were no difficulties encountered while attempting to insert, advance, or withdraw the device.There was no blood transfusion required due to the leakage.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.

Manufacturer Narrative

As reported, the hub of a 6f.070 jl3.5 100cm guiding catheter is cracked and drips blood.There was no reported patient injury.The device was stored and prepped according to the ifu.There was no device or package damage noted prior to use.The device was pulled from the packaging and was handled as recommended by the ifu.The device was not torqued or steered by the hub.There were no difficulties encountered while attempting to insert, advance, or withdraw the device.There was no blood transfusion required due to the leakage.One non-sterile 6f.070 jl3.5 100cm was received for analysis.During the visual analysis neither the hub nor the body of the unit presented with any damaged condition along the unit.A high magnification visual analysis using a vision system was completed and a crack was observed on the hub of the device.Additionally, the separation borders of the crack presented evidence of elongations and striation patterns.The reported "luer hub-cracked" was confirmed.The returned unit presented with a cracked condition on the luer hub.The elongations and striation patterns found on the hub are commonly associated with separations caused by material tensile overload.While the exact cause of the crack cannot be conclusively determined during the analysis, it is assumed the hub was induced to a tensile force that exceeded its yield strength prior to cracking.Storage or handling factors may have contributed to the 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 preventative or corrective actions will be taken at this time.

• Brand Name: VISTA BRITE TIP
• 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: 19050817
• MDR Text Key: 339481596
• Report Number: 9616099-2024-00105
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 04/05/2024

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: 67000200
• Device Lot Number: 18258741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• 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