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

Catalog Number	451414H0
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
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, during angiography, a 4f 100 cm vertebral (vert) tempo catheter was found with damaged outer packaging, and the guidewire exhibited a twisted and contaminated end.The product was replaced, and the supplier was notified.There was no reported patient injury.The device is expected to be returned for evaluation.This case was reported to the china nmpa as an adverse event.
Additional Manufacturer Narrative
As reported, during angiography, a 4f 100 cm vertebral (vert) tempo catheter was found with damaged outer packaging, and the guidewire exhibited a twisted and contaminated end.The product was replaced, and the supplier was notified.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The product was not returned for analysis.A product history record (phr) review of lot 18447859 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported malfunctions ¿packaging/pouch/box ¿ damaged ¿ inner package,¿ ¿packaging/pouch/box ¿ compromised sterility ¿ sterile barrier breached,¿ and ¿catheter (body/shaft) ¿ kinked/bent¿ could not be confirmed because the device was not returned and images were not provided.The exact cause of the reported event cannot be determined.User compliance with the product labeling was not provided therefore, storage and handling factors cannot be excluded.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ 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.
Event or Problem Description
The product was not returned for analysis.

• 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: 22913309
• Report Number: 9616099-2025-01384
• Device Sequence Number: 15758390
• Product Code: DQO
• UDI-Device Identifier: 10705032007856
• UDI-Public: (01)10705032007856(17)280430(10)18447859
• 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): 10/09/2025

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 Catalogue Number: 451414H0
• Device Lot Number: 18447859
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• 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