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

Catalog Number 67005400

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/02/2024

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, service declared that the carrier probe of a 6f vista brite tip extra back-up 3.5 (xb 3.5) guiding catheter is defective, having been pierced at its origin, and is unusable.There was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

As reported, service declared that the carrier probe of a 6f vista brite tip extra back-up 3.5 (xb 3.5) guiding catheter is defective, having been pierced at its origin, and is unusable.There was no reported patient injury.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)-puncture/cut¿ could not be confirmed.Storage, procedural and/or handling factors may have contributed to the reported event.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 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.¿ based on the available information, 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 Description

Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for evaluation.

• 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 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18817423
• MDR Text Key: 337211305
• Report Number: 9616099-2024-00068
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 67005400
• Device Lot Number: 18254010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2023
• 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: N/A.