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

Catalog Number 67012700

Device Problem Leak/Splash (1354)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

As reported, there was blood on the hub side of a 6f.070in extra back-up (xb) rca sidehole (sh) 100cm vista brite tip guiding catheter.There were no reports of patient injury.The user tried to use the vista brite tip for percutaneous coronary intervention (pci), but he was not able to use it due to the issue found.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.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h2, h3, h6, and h10.Complaint conclusion: as reported, there was blood on the hub side of a 6f.070in extra back-up (xb) rca sidehole (sh) 100cm vista brite tip guiding catheter.There were no reports of patient injury.The user tried to use the vista brite tip for percutaneous coronary intervention (pci), but he was not able to use it due to the issue found.A non-sterile unit of catheter 6f.070 xb rca sh 100cm was received for evaluation.During the visual inspection, a kinked/bent condition was observed on the body of the catheter located 69.9 cm from the distal tip.No other damages or anomalies were observed on the returned device when viewed by the naked eye.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A leakage test was performed on the hub by attaching a syringe and injecting water.A crack was noted on the hub when attaching the syringe.Sem analysis was performed on the cracked hub and presented evidence of fatigue striations and plastic deformation.The reported ¿luer hub - leakage¿ and ¿luer hub-cracked¿ was confirmed since leakage from a cracked hub was noted during the functional test.Plastic deformation and fatigue striations 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.

Event Description

As reported, there was blood on the hub side of a 6f.070in extra back-up (xb) rca sidehole (sh) 100cm vista brite tip guiding catheter.There were no reports of patient injury.The user tried to use the vista brite tip for percutaneous coronary intervention (pci), but he was not able to use it due to the issue found.The device was returned for evaluation.Addendum: per pe findings, a crack was noted on the hub when attaching the syringe.

• Brand Name: VISTA BRITE TIP
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US. CORP; 14021 nw 60 avenue; miami lakes, florida 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: 19069739
• MDR Text Key: 339685360
• Report Number: 9616099-2024-00108
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/09/2024

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: 67012700
• Device Lot Number: 18250794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2023
• 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