MAUDE Adverse Event Report: CORDIS US CORP. TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	451431H0
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the hub of a 4f sim 2 100cm tempo diagnostic catheter was leaking.There was no reported patient injury.The intended procedure was a middle meningeal artery (mma) embolization.The leak was identified at the hub where the catheter connects to the luer end and was noticed when attempting to perform a hand injection.A contralateral approach was not used.The access site vessel was described as normal.The device was flushed prior to use, and the sheath dilator was securely connected at the hub.No difficulties were encountered during insertion or withdrawal.The product was stored and handled according to the instructions for use.No device damage was noted prior to opening the package.There was no difficulty removing the device from the sterile packaging.No unusual force was used during the procedure, and no difficulties were encountered while inserting or withdrawing any concomitant devices.The device will be returned for evaluation.
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.
Additional Manufacturer Narrative
As reported, the hub of a 4f sim 2 100cm tempo diagnostic catheter was leaking.There was no reported patient injury.The intended procedure was a middle meningeal artery (mma) embolization.The leak was identified at the hub where the catheter connects to the luer end and was noticed when attempting to perform a hand injection.A contralateral approach was not used.The access site vessel was described as normal.The device was flushed prior to use, and the sheath dilator was securely connected at the hub.No difficulties were encountered during insertion or withdrawal.The product was stored and handled according to the instructions for use.No device damage was noted prior to opening the package.There was no difficulty removing the device from the sterile packaging.No unusual force was used during the procedure, and no difficulties were encountered while inserting or withdrawing any concomitant devices.The device was not returned for evaluation.A product history record (phr) review of lot 18397936 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub ¿ leakage¿ could not be substantiated because the device as not returned for evaluation and images were not provided.The exact cause of the event cannot be determined however, no damage was noted while opening the package, the device was flushed prior to use and no difficulties were noted during insertion therefore, handling factors cannot be excluded.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 of making the user aware of the risks.According to the instructions for use (ifu), ¿treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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 ; 7863138372
• MDR Report Key: 24223292
• Report Number: 9616099-2026-00167
• Device Sequence Number: 8197043
• Product Code: DQO
• UDI-Device Identifier: 10705032007948
• UDI-Public: (01)10705032007948(17)271130(10)18397936
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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: 451431H0
• Device Lot Number: 18397936
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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: Female