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

Catalog Number	6700820E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during an angiogram procedure, a 6f judkins right 4 (jr4) vista brite tip guiding catheter became kinked and the physician was unable to remove it.It was determined that the patient needed a higher level of care and was transported to another medical center for its removal.The product was stored and handled according to the instructions for use (ifu), and no damage was noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device was prepped according to the ifu, and no issues were experienced during preparation.It is not specified whether another vista brite tip was used to complete the procedure.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, during an angiogram procedure, a 6f judkins right 4 (jr4) vista brite tip guiding catheter became kinked and the physician was unable to remove it.It was determined that the patient needed a higher level of care and was transported to another medical center for its removal.The product was stored and handled according to the instructions for use (ifu), and no damage was noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device was prepped according to the ifu, and no issues were experienced during preparation.It is not specified whether another vista brite tip was used to complete the procedure.A procedural cd is not available.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18442188 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint ¿catheter (body/shaft) kinked/bent catheter (body/shaft) withdrawal difficulty from vessel¿ could not be evaluated.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.It is possible that vessel characteristics, which were not reported, may have led to the kink in the catheter and that consequently led to issues with withdrawal of the catheter.All catheters require torquing, which is a dynamic process once it enters the patient due to external factors such as temperature, time of exposure in body, individual patient anatomical structures, storage conditions, and operator technique in torquing and manipulating the catheter.If a catheter does not move as expected, the operator is trained to stop and investigate the cause before continuing to avoid further damage to the catheter, such as a kinks, bends, and even separations.Based on the information available for review, there is no indication to suggest that the reported incident could be related to the design or manufacturing process of the units.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 60th avenue; miami lakes
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 22488900
• Report Number: 9616099-2025-01103
• Device Sequence Number: 18152939
• Product Code: DQY
• UDI-Device Identifier: 10705032020442
• UDI-Public: (01)10705032020442(17)280331(10)18442188
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6700820E
• Device Lot Number: 18442188
• Was Device Available for Evaluation?: Yes
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/12/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown