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

Catalog Number 67008200

Device Problem Leak/Splash (1354)

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

Event Date 12/17/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, blood leakage was found at the connection between the y-valve and the 6f 100 cm vista brite tip judkins right (jr4) guiding catheter after reaching the right coronary orifice during intracoronary intervention.The y-valve was replaced with another one; but the leakage was still present.The guiding catheter was then replaced, and no further leakage occurred.The procedure was completed successfully.There was no reported patient injury.During the operation, the patient's condition and treatment were not affected by the problem with the catheter.Lesion calcification and vessel tortuosity was mild with ninety-five percent (95%) stenosis.There were no anomalies noted when the device was taken out of the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The device was flushed prior to use and a continuous flush was maintained throughout the procedure.There were no difficulties encountered while inserting or withdrawing any concomitant devices.No excess force was used during the procedure.The device was not returned for evaluation.Without the return of the device or images for analysis, the reported customer event ¿luer hub-leakage¿ could not be confirmed.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.¿ 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, a blood leakage was found at the connection between the y-valve and the 6f 100 cm vista brite tip judkins right (jr4) guiding catheter after reaching the right coronary orifice during intracoronary intervention.The y-valve was replaced with another one; but the leakage was still present.The guiding catheter was then replaced, and no further leakage occurred.The procedure was completed successfully.There was no reported patient injury.During the operation, the patient's condition and treatment were not affected by the problem with the catheter.Lesion calcification and vessel tortuosity was mild with ninety-five percent (95%) stenosis.There were no anomalies noted when the device was taken out of the package.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was no difficulty experienced in prepping the device.The device was flushed prior to use and a continuous flush was maintained throughout the procedure.There were no difficulties encountered while inserting or withdrawing any concomitant devices.No excess force was used during the procedure.The device will not be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.Please upgrade this case to ae.

• Brand Name: VISTA BRITE TIP
• Type of Device: CATHETER, PERCUTANEOUS
• 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 18548288
• MDR Text Key: 333546236
• Report Number: 9616099-2024-00026
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/19/2024

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: 67008200
• Device Lot Number: 18241896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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
• Treatment: UNKNOWN CORDIS GUIDING CATHETER.
• Patient Age: 69 YR
• Patient Sex: Female