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

Catalog Number	451443V0
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 4f c2 65cm tempo diagnostic catheter was severed by the puncture.There was no reported patient injury.This occurred during a lumbar embolization.Additional information was requested but is not available.The device will not be returned for evaluation as the device was destroyed.
Additional Manufacturer Narrative
As reported, a 4f c2 65cm tempo diagnostic catheter was severed by the puncture.There was no reported patient injury.This occurred during a lumbar embolization.Additional information was requested but is not available.The device will not be returned for evaluation as the device was discarded.A product history record (phr) review of lot 18449578 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) ¿ puncture/cut¿ could not be substantiated because the device was not returned for evaluation, no images were provided, and limited event details were available, preventing confirmation of the reported damage or determination of the failure mechanism.As a result, the investigation was limited to a review of available documentation and manufacturing history.Although the cause of the reported event remains undetermined, the investigation did not identify evidence of a new or increased residual risk beyond those already addressed by existing risk controls.Based on the available information, there is no evidence to suggest the event is related to the device design or manufacturing process; therefore, no further action will be taken at this time.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14021 nw 60 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: 23600990
• Report Number: 9616099-2025-01873
• Device Sequence Number: 15932177
• Product Code: DQO
• UDI-Device Identifier: 10705032008051
• UDI-Public: (01)10705032008051(17)280428(10)18449578
• 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): 01/19/2026

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: 451443V0
• Device Lot Number: 18449578
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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 Sex: Unknown