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

Catalog Number	67008000
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the distal tip of a 6f 100cm judkins right (jr) 3.5 vista brite tip guiding catheter was found to be fractured.An unknown guiding catheter was used to complete the procedure.There were no reported injuries to the patient and no signs of infectious disease.This was during a percutaneous coronary intervention (pci) procedure in which angiography revealed a greater than 80% stenosis of the left anterior descending (lad) coronary artery.The operator had been trained.Additional information was requested but was not provided.The device will be returned for evaluation.
Additional 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: a2, a4, b4, b5, d10, g3, g6, h1, h2, h3, and h11.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.
Event or Problem Description
As reported, the distal tip of a 6f 100cm judkins right (jr) 3.5 vista brite tip guiding catheter was found to be fractured during preparation.The catheter tip fractured but remained attached to the catheter.A non-cordis guiding catheter was used to complete the procedure.There were no reported injuries to the patient and no signs of infectious disease.This was during a percutaneous coronary intervention (pci) procedure in which angiography revealed a greater than 80% stenosis of the left anterior descending (lad) coronary artery.The vessel characteristics at the target site included bifurcation, mild calcification, and mild tortuosity.The operator had been trained.The device was stored and prepped per the instruction for use (ifu).The catheter did not become entrapped at any point in the procedure as the defect was found during preparation.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the distal tip of a 6f 100cm judkins right (jr) 3.5 vista brite tip guiding catheter was found to be fractured during preparation.The catheter tip fractured but remained attached to the catheter.A non-cordis guiding catheter was used to complete the procedure.There were no reported injuries to the patient and no signs of infectious disease.This was during a percutaneous coronary intervention (pci) procedure in which angiography revealed a greater than 80% stenosis of the left anterior descending (lad) coronary artery.The vessel characteristics at the target site included bifurcation, mild calcification, and mild tortuosity.The operator had been trained.The device was stored and prepped per the instruction for use (ifu).The catheter did not become entrapped at any point in the procedure as the defect was found during preparation.A non-sterile 6f.070 jr 3.5 100cm catheter was received coiled in a plastic bag.Visual inspection revealed two kinked or bent sections located approximately 14.5 cm and 77.2 cm from the distal tip, while the brite tip and distal tip remained undamaged.No additional anomalies were observed.Dimensional measurements taken near the kinked areas confirmed that both the outer and inner diameters were within specified limits.The reported ¿brite tip/distal tip- cracked¿ was not observed during product analysis.The device presented with two kinked/bent conditions and no cracks/fractures were seen.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 of making 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 and product analysis, there is no evidence to suggest 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
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 21854822
• Report Number: 9616099-2025-00648
• Device Sequence Number: 17323827
• Product Code: DQY
• UDI-Device Identifier: 20705032020418
• UDI-Public: (01)20705032020418(17)251231(10)18181089
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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 Expiration Date: 12/31/2025
• Device Catalogue Number: 67008000
• Device Lot Number: 18181089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 05/14/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/12/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC CATHETER; UNKNOWN CATHETER; UNKNOWN SHEATH
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 65 KG