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

Catalog Number 67008200

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

As reported, the tip end of a vista brite tip 6f.070 judkins right 4 100cm guiding catheter was found to be fractured.The radiopaque distal tip was separated.Immediately upon the removal of the catheter, it was noticed that the ¿braidless segment¿ of the tip end was missing.There was no reported patient injury.The device was not used in the patient.The mid right coronary artery (rca) was the target lesion.The lesion was not calcified, had no tortuosity and no angulation.The vessel had 75% stenosis.The device was not used for a chronic total occlusion (cto).The device was not resterilized.There were no anomalies noted when removed from the package or during prep.The device did not separate inside the patient.The status of the patient is ¿normal¿.There was no resistance met while advancing the device over the guidewire.There was no device kink in the area of separation.There was no resistance met while withdrawing the device.The separation was found before inserting into the patient.The device will be returned for evaluation.

Manufacturer Narrative

-a review of the manufacturing documentation associated with lot 18167785 presented no issues during the manufacturing process that can be related to the reported event.-additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the distal tip of a vista brite tip 6f.070 judkins right 4 100cm guiding catheter was found to be fractured.The radiopaque distal tip was separated.Immediately upon the removal of the catheter, it was noticed that the ¿braidless segment¿ of the tip end was missing.There was no reported patient injury.The device was not used in the patient.The mid right coronary artery (rca) was the target lesion.The lesion was not calcified, had no tortuosity and no angulation.The vessel had 75% stenosis.The device was not used for a chronic total occlusion (cto).The device was not re-sterilized.There were no anomalies noted when removed from the package or during prep.The device did not separate inside the patient.The status of the patient is ¿normal¿.There was no resistance met while advancing the device over the guidewire.There was no device kink around separation.There was no resistance met while withdrawing the device.The separation was found before inserting into the patient.A non-sterile unit of catheter 6f.070 jr 4 100cm was received for analysis.During visual inspection, several kinks were noted 52cm and 83cm from the distal tip.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.The brite tip was observed under the vision system and it was observed that the tip was prolapsed.A product history record (phr) review of lot 18167785 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿brite tip/distal tip- separated¿ was not confirmed because a separation was not found at the distal tip.However, a prolapsed condition to the distal tip and several kinks were noted on the returned device.Shipping, storage, or 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 is suitable for the specific procedure.¿ based on the information available and the phr review, 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.

Manufacturer Narrative

This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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.

• 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 ; 7863138372
• MDR Report Key: 17755427
• MDR Text Key: 323500712
• Report Number: 9616099-2023-06596
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032020432
• UDI-Public: (01)20705032020432(17)251031(10)18167785
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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: 18167785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• 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: EMERALD 150CM J CURVE GUIDEWIRE (502521); TERUMO TIG CATHETER