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

Model Number	67008200
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the tip of the 6f vista brite tip 0.70 judkins right (jr) guiding catheter was found frayed/split/torn when the operator removed the product from the package before a percutaneous coronary intervention (pci) procedure.The product did not enter the body.There was no reported patient injury.Prior to opening the packaging there was no device damage noticed.There was no difficulty removing the device from the sterile packaging.Neither the product nor any of the other devices used with it had been re-sterilized.The device was not returned for evaluation.A product history record (phr) review of lot 18091359 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip-frayed/split/torn¿ could not be confirmed or further clarified.Given the limited information provided an exact cause for the event could not be determined.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, ¿do not use if package is open or damaged.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Inspect the guiding catheter before use to verify that its size, shape and condition are 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.
Event or Problem Description
As reported, the tip of the 6f vista brite tip 0.70 judkins right (jr) guiding catheter was found frayed/split/torn when the operator removed the product from the package before a percutaneous coronary intervention (pci) procedure.The the product did not enter the body.There was no reported patient injury.Prior to opening the packaging there was no device damage noticed.There was no difficulty removing the device from the sterile packaging.Neither the product nor any of the other devices used with it had been re-sterilized.The product cannot be returned for evaluation.

• Brand Name: VISTA BRITE TIP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16860574
• Report Number: 9616099-2023-06479
• Device Sequence Number: 5421057
• Product Code: DQY
• UDI-Device Identifier: 20705032020432
• UDI-Public: (01)20705032020432(17)250228(10)18091359
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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 Expiration Date: 02/28/2025
• Device Model Number: 67008200
• Device Catalogue Number: 67008200
• Device Lot Number: 18091359
• Was Device Available for Evaluation?: No
• 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: 04/07/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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: UNK.
• Patient Sex: Unknown