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

Catalog Number	451504V5
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	03/12/2026
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, the distal end of the 5f uf 65cm tempo catheter became bent and detached while on the wire.The wire, catheter and broken portion was pulled out of the sheath with no harm to the patient.The break occurred while attempting to advance the catheter up and over the iliac bifurcation.No unusual force was applied, although the iliac vessels were noted to be tortuous.The intended procedure was a leg angiogram for distal disease.The lesion had little or no calcification, and vessel tortuosity was present.The device was stored and prepped according to the instructions for use (ifu).Devices are stored hanging on a catheter supply cart and are sometimes kept in procedure or supply areas during room turnover, without exposure to outdoor light or advanced decontamination methods such as uv-c, vhp, ozone, or fogging.Devices are removed from the outer box and stored on hangers with other catheters, not in cabinets.Storage environments are climate controlled with no known facility issues (e.G., hvac, humidity, leaks) or recent changes to cleaning or storage practices.The device is not reprocessed or exposed to uv or sterilization processes.A non-cordis guidewire was used.The device is not being returned.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 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: 24784463
• Report Number: 9616099-2026-00469
• Device Sequence Number: 10036790
• Product Code: DQO
• UDI-Device Identifier: 10705032008327
• UDI-Public: (01)10705032008327(17)281130(10)18537833
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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
• Device Catalogue Number: 451504V5
• Device Lot Number: 18537833
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/04/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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: COOK GUIDEWIRE
• Patient Sex: Unknown