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

Catalog Number	451430H0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
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, a 4f 100cm sidewinder simmons technique 1 (sim1) tempo diagnostic catheter developed a kink and the distal end fractured.There were no reported injuries to the patient.The device will be returned for evaluation.The hospital reported this case as an adverse event to the china nmpa.
Additional Manufacturer Narrative
As reported, a 4f 100cm sidewinder simmons technique 1 (sim1) tempo diagnostic catheter developed a kink and the distal end fractured.There were no reported injuries to the patient.The device was not returned for evaluation.A product history record (phr) review of lot 35271538 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) ¿ kinked/bent and brite tip/distal tip ¿ cracked¿ could not be substantiated because the device was not returned and images were not provided.Consequently, confirmation of the reported condition and assessment of device condition at the time of preparation were not possible.Based on the available information, the root cause of the reported event remains undetermined, and procedural or handling-related factors cannot be ruled out.Labeling was reviewed at a high level; however, due to insufficient information regarding the device condition and sequence of events, the applicability of specific ifu instructions could not be assessed.There is no evidence from the information reviewed to suggest the event is related to device design or manufacturing processes, and no further actions are indicated at this time.
Event or Problem Description
As reported, a 4f 100cm sidewinder simmons technique 1 (sim1) tempo diagnostic catheter developed a kink and the distal end fractured.There were no reported injuries to the patient.The device will be returned for evaluation.

• 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: 24093837
• Report Number: 9616099-2026-00111
• Device Sequence Number: 16013339
• Product Code: DQO
• UDI-Device Identifier: 10705032007924
• UDI-Public: (01)10705032007924(17)271231(10)18411629
• 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): 02/25/2026

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: 451430H0
• Device Lot Number: 18411629
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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