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

Catalog Number	451413H0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the hub of a 4f berenstein (ber) 100cm tempo diagnostic catheter broke off from the shaft.There was no reported patient injury.The device was returned for evaluation.
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the hub of a 4f berenstein (ber) 100cm tempo diagnostic catheter broke off from the shaft.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.A non-sterile cath tempo 4f ber 100cm device was returned for evaluation, while the hub component was not returned.Visual inspection identified a separation located approximately 98.0 cm from the distal tip.Dimensional analysis was performed near the separation site.The inner and outer diameters were found within specification, confirming no dimensional nonconformance.Microscopic evaluation of the separated region revealed evidence of plastic deformation and multiple areas of material elongation at the separation interface.These observations are consistent with mechanical stress, such as excessive bending, tensile loading, or interaction with another surface or device, resulting in forces exceeding the material¿s yield strength.The overall analysis did not identify evidence of manufacturing or design-related issues associated with the reported event.The reported ¿luer hub ¿ separated¿ could not be substantiated because the luer hub was not returned.However, the reported ¿catheter (body/shaft) ¿ separated¿ was observed.The exact cause of this event cannot be determined however, the device presented with signs of mechanical stress, such as excessive bending, tensile loading, or interaction with another surface or device, resulting in forces exceeding the material¿s yield strength.Therefore, use related factors cannot be excluded.According to the instructions for use (ifu), ¿treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ 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.

• 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: 24547246
• Report Number: 9616099-2026-00359
• Device Sequence Number: 5724887
• Product Code: DQO
• UDI-Device Identifier: 10705032007832
• UDI-Public: (01)10705032007832(17)280630(10)18479058
• 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): 04/15/2026

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: 451413H0
• Device Lot Number: 18479058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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 Sex: Unknown