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

Catalog Number	451506P0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a moveable foreign object was found in a 5f multipurpose (mp) a1 (i) 125cm tempo diagnostic catheter during flushing with normal saline prior to an intracranial thrombectomy procedure.Another tempo device was used to complete the procedure.There was no reported patient injury.The procedure involved treatment for an acute cerebral infarction.The product was stored, handled, and prepared according to the instructions for use (ifu), and no damage was noted before opening the package.There were no difficulties removing the device from sterile packaging or preparing it, and no component damage was identified prior to use.The device will not be returned for evaluation.The event was reported to the china regulatory authority as a serious injury adverse event by the hospital.
Additional Manufacturer Narrative
As reported, a moveable foreign object was found in a 5f multipurpose (mp) a1 (i) 125cm tempo diagnostic catheter during flushing with normal saline prior to an intracranial thrombectomy procedure.Another tempo device was used to complete the procedure.There was no reported patient injury.The procedure involved treatment for an acute cerebral infarction.The product was stored, handled, and prepared according to the instructions for use (ifu), and no damage was noted before opening the package.There were no difficulties removing the device from sterile packaging or preparing it, and no component damage was identified prior to use.A product history review (phr) was performed by the failure analysis lab for lot 18474379 and no evidence of manufacturing related issues impacting released product was identified.The reported ¿catheter (body/shaft) ¿ foreign material¿ could not be substantiated because the device was not returned and images were not provided.The exact cause of the reported event cannot be determined and the introduction of the foreign material after opening the packaging cannot be excluded.No labeling-related condition could be identified from the information provided; however, because the device was not returned and images were not provided, a definitive assessment of labeling contribution cannot be made.Based on the available information and phr, 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: 23898716
• Report Number: 9616099-2025-02068
• Device Sequence Number: 18671024
• Product Code: DQO
• UDI-Device Identifier: 10705032008358
• UDI-Public: (01)10705032008358(17)280630(10)18474379
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 451506P0
• Device Lot Number: 18474379
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 68 YR
• Patient Sex: Male