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)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the luer lock hub of a 6f.070-inch extra backup (xb) 3.5 eco pack guiding catheter was defective out of the package.There was no reported patient injury.The reported issue involved a guiding catheter that did not appear as expected out of the package.The customer was unsure how to describe the damage and noted they had not personally seen the catheter.The intended procedure was a left coronary percutaneous coronary intervention (pci).Another extra backup (xb) 3.5 eco pack guiding catheter was used to complete the procedure.The device was stored and handled according to the instructions for use (ifu), and there was no damage observed prior to opening the package.There were no issues removing the device from the sterile packaging, and it was prepped according to the ifu without difficulty.The 6f.070 xb 3.5 eco pk device was returned for investigation and underwent visual, functional, and microscopic evaluation.Unaided visual inspection of the received unit did not reveal any abnormal conditions.A flushing evaluation was attempted; however, it could not be completed due to a crack noted on the luer hub.High-magnification microscopic evaluation of the luer hub surface identified a crack extending from the proximal end to the middle portion of the component in a ¿j¿-shaped pattern.The received unit was confirmed to have a crack on the luer hub surface, and the inability to complete flushing was attributed to this condition.Microscopic analysis verified the crack propagation pattern along the luer hub, and the observed condition was identified as related to a known manufacturing issue.The reported ¿luer hub~cracked¿ was confirmed.The returned unit presented with a cracked condition on the luer hub.The exact cause of the observed damage could not be conclusively determined during the analysis.It is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to cracking.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 appears to be related to the manufacturing process of the unit and an investigation has been initiated to further review the potential causes.No further action will be taken at this time.
Event or Problem Description
As reported, the luer lock hub of a 6f.070-inch extra backup (xb) 3.5 eco pack guiding catheter was defective out of the package.There was no reported patient injury.The reported issue involved a guiding catheter that did not appear as expected out of the package.The customer was unsure how to describe the damage and noted they had not personally seen the catheter.The intended procedure was a left coronary percutaneous coronary intervention (pci).Another extra backup (xb) 3.5 eco pack guiding catheter was used to complete the procedure.The device was stored and handled according to the instructions for use (ifu), and there was no damage observed prior to opening the package.There were no issues removing the device from the sterile packaging, and it was prepped according to the ifu without difficulty.The device was 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 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: 24046659
• Report Number: 9616099-2026-00081
• Device Sequence Number: 13135084
• Product Code: DQY
• UDI-Device Identifier: 10705032020176
• UDI-Public: (01)10705032020176(17)280731
• 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): 01/12/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6700540E
• Device Lot Number: 18491754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• 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: 01/07/2026
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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