MAUDE Adverse Event Report: Cordis US. Corp TEMPO; Catheter, Intravascular, Diagnostic

Catalog Number	451414H0
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of a 4f 100cm vertebral (vert) tempo diagnostic catheter was split.A new 4f 100cm vert tempo diagnostic catheter was used as a replacement.There were no reported injuries to the patient.An unknown 4f sheath and unknown j-wire were used during the procedure.The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.

• 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 32574 ; MX 32574 ; +011(786)3138372
• MDR Report Key: 50914625
• Report Number: 9616099-2026-01369
• Device Sequence Number: 17478931
• Product Code: DQO
• UDI-Device Identifier: 10705032007856
• UDI-Public: (01)10705032007856(17)281231(10)18542561
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 451414H0
• Device Lot Number: 18542561
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2026
• 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: 4F 100cm VERT Tempo diagnostic catheter; Unknown 4F sheath; Unknown J-wire
• Patient Sex: Unknown