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

Catalog Number SM7398

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  malfunction  

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 Description

As reported, a 6f 100 cm amplatz right mod guiding catheter was noted to be leaking blood at the hub of the catheter during use, despite adequate connection to the luer.Another cordis device was used to complete the intended procedure which was reported to be a percutaneous coronary intervention (pci).There was no reported patient injury.The device was opened in sterile field.There was no obvious damage to the catheter as it was advanced over the wire, into the patient.The product was stored as per labeling and was opened in sterile field.There was no difficulty experienced in prepping the device.Prior to use, the guiding catheter lumen was flushed with a heparinized saline solution.A continuous heparinized saline flush was not set up through the sidearm of a hemostatic valve attached to the guiding catheter hub.The device is expected to be returned for evaluation.

Manufacturer Narrative

As reported, despite adequate connection to the luer, a 6f 100 cm vista brite tip amplatz right (ar) mod guiding catheter was noted to be leaking blood at the hub of the catheter during use.Another cordis device was used to complete the intended procedure which was reported to be a percutaneous coronary intervention (pci).There was no reported patient injury.The device was opened in the sterile field.There was no obvious damage to the catheter as it was advanced over the wire and into the patient.The product was stored as per labeling.There was no difficulty experienced in prepping the device.Prior to use, the guiding catheter lumen was flushed with a heparinized saline solution.A continuous heparinized saline flush was not set up through the sidearm of a hemostatic valve attached to the guiding catheter hub.One non-sterile gc 6f vbt.070 100cm ar mod was received for analysis.During visual analysis, the unit¿s body presented with a kink located 24 cm from the proximal hub.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.A high magnification analysis using sem equipment was performed on the hub to evaluate the reported defect and a crack with fatigue striation and elongation patterns was identified.The reported ¿luer hub - leakage¿ was confirmed as a failure that is secondary to the confirmed malfunction ¿luer hub ¿ cracked.¿ the exact cause of these events cannot be determined however, plastic deformation (fatigue striation and elongation patterns) is commonly associated with damages caused when resistance properties are overloaded.Storage or handling factors that placed excessive stress on the device may have caused the damages (crack and kink).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, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

Manufacturer Narrative

The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: VISTA BRITE TIP
• Type of Device: 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 FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18597230
• MDR Text Key: 333978629
• Report Number: 9616099-2024-00035
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

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 Catalogue Number: SM7398
• Device Lot Number: 18179073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/14/2024; 04/17/2024
• Supplement Dates FDA Received: 02/14/2024; 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDEWIRE.