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

Catalog Number	451503H5
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the port of a 5f pig 100cm tempo diagnostic catheter was found to be uneven and could not connect to the y-connector while preparing to perform a procedure.The catheter was immediately replaced, and the replacement functioned normally.There was no reported patient injury.The issue delayed the patient¿s treatment.The device will be returned for evaluation.The hospital reported this case as an adverse event to the china nmpa.
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 port of a 5f pig 100cm tempo diagnostic catheter was found to be uneven and could not connect to the y-connector while preparing to perform a procedure.The catheter was immediately replaced, and the replacement functioned normally.There was no reported patient injury.The issue delayed the patient¿s treatment.Multiple attempts were made to obtain supplemental information; however, no additional event details were provided.The device was not returned for evaluation as anticipated.A product history record (phr) review of lot 18435153 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub ¿ incompatibility/fit¿ cannot be substantiated because the device was not returned and images were not provided.The exact cause of the event cannot be determined, and handling factors cannot be excluded.Labeling relevance could not be fully assessed due to limited event information (device not returned for evaluation, no photographs provided, and no additional details obtained despite follow-up).Based on review of the provided ifu excerpt, no statements were identified that address luer hub/connector fit or inability to connect to an accessory (e.G., y-connector).Routine clinical setup practices typically include confirming accessory connections and device readiness prior to use; however, because the event mechanism cannot be characterized from available information, a determination regarding residual risk communication cannot be made.Based on the available information, 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: 24097399
• Report Number: 9616099-2026-00120
• Device Sequence Number: 13361299
• Product Code: DQO
• UDI-Device Identifier: 10705032008273
• UDI-Public: (01)10705032008273(17)280331(10)18435153
• 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): 03/02/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 451503H5
• Device Lot Number: 18435153
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/22/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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 Age: 67 YR
• Patient Sex: Male