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

Catalog Number	6700540E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, pieces of the hubs of a 6f infiniti diagnostic catheter and a 6f vista brite tip guiding catheter consistently broke off during the procedure.There was no reported patient injury.The exact event date is unknown.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The devices were returned for evaluation.
Additional Manufacturer Narrative
As reported, pieces of the hubs of a 6f infiniti diagnostic catheter and a 6f vista brite tip guiding catheter consistently broke off during the procedure.There was no reported patient injury.The exact event date is unknown.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The 6f.070 xb 3.5 eco pk device was returned for evaluation.Visual inspection identified no abnormalities or damage on the received unit.Functional testing using a cordis lab sample syringe demonstrated leakage at the hub during flushing simulation.Additionally, aspiration testing in vacuum mode confirmed that only air was drawn into the syringe.Microscopic evaluation of the hub identified a crack located at the top of the luer hub body, extending along the length of the hub.Based on these findings, the observed leakage and aspiration behavior are attributed to the presence of the crack in the luer hub.The reported "luer hub ¿ splintered ¿ fragments cannot be injected¿ was not seen during the product evaluation.However, the reported ¿luer hub ¿ cracked ¿was observed.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 and product analysis, the cause of the luer hub crack could not be determined; however, it could be related to the manufacturing process of the unit.Therefore, an investigation has been initiated to further review the potential causes.No further action will be taken at this time.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 24703719
• Report Number: 9616099-2026-00410
• Device Sequence Number: 21343738
• Product Code: DQY
• UDI-Device Identifier: 10705032020176
• UDI-Public: (01)10705032020176(17)280630(10)18478838
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6700540E
• Device Lot Number: 18478838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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
• Patient Sex: Unknown