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

Catalog Number	451524H0
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported, the catheter body of a 5f judkins right (jb) 2 100cm tempo diagnostic catheter disintegrated during the embolization procedure, despite being within its shelf life, sterile, and without any packaging issues.There was no reported patient injury.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, the catheter body of a 5f judkins right (jb) 2 100cm tempo diagnostic catheter disintegrated during the embolization procedure, despite being within its shelf life, sterile, and without any packaging issues.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for evaluation as expected.The product was not returned for analysis.A product history record (phr) review of lot 18199607 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for review the reported ¿strain reilef-degradation¿ could not be substantiated and the exact cause of the reported event cannot be found.Users are trained to inspect products for signs of damage prior to and during use, and any product showing damage is not to be used.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the information available, there is no evidence to suggest the reported event is related to design or manufacturing issues.Therefore, no action will be taken.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• 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: 23351069
• Report Number: 9616099-2025-01698
• Device Sequence Number: 8806930
• Product Code: DQO
• UDI-Device Identifier: 10705032008549
• UDI-Public: (01)10705032008549(17)260331(10)18199607
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 451524H0
• Device Lot Number: 18199607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• 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 Sex: Unknown