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

Catalog Number 67008200

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

As reported a split was noted at the tip end of the 6f judkins right 4 (jr4) vista brite tip guiding catheter.The device was used in the patient.Another vista brite tip was used to complete the procedure.There was no reported patient injury.The lesion was the common right coronary, and the access site was radial.There was no lesion calcification or tortuosity and ninety per cent (90%) stenosis.The device was not used for a chronic total occlusion.There were no anomalies noted when the device was taken out of the package or device damage noticed prior to opening the package nor difficulty removing the device from the sterile packaging.The device was stored and prepped with no difficulty as per the instructions for use (ifu).The device was not returned for evaluation.

Manufacturer Narrative

As reported a split was noted at the tip end of the 6f judkins right 4 (jr4) vista brite tip guiding catheter.The device was used in the patient.Another vista brite tip was used to complete the procedure.There was no reported patient injury.The lesion was the common right coronary, and the access site was radial.There was no lesion calcification or tortuosity and ninety per cent (90%) stenosis.The device was not used for a chronic total occlusion.There were no anomalies noted when the device was taken out of the package.No device damage was noticed prior to opening the package and there was no difficulty removing the device from the sterile packaging.The device was stored and prepped with no difficulty as per the instructions for use (ifu).The device was not returned for evaluation.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal-frayed/split/torn¿ 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.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, 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: 19005950
• MDR Text Key: 339209013
• Report Number: 9616099-2024-00097
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 18242966
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2023
• 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: CORDIS.