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

Model Number	N/A
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	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the distal end of a 5f tempo vertebral (vert) 100cm angiographic catheter was missing during preparation for use, and the detached segment could not be located.A new catheter was used to complete the procedure, which extended the operation time.There was no reported patient injury.The hospital reported the event as a serious injury adverse event to the china nmpa.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, the distal end of a 5f tempo vertebral (vert) 100cm angiographic catheter was missing during preparation for use, and the detached segment could not be located.A new catheter was used to complete the procedure, which extended the operation time.There was no reported patient injury.The hospital reported the event as a serious injury adverse event to the china nmpa.Additional information was requested but not provided.The device was not returned as expected.A product history record (phr) review of lot 18456348 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip ¿ separated¿ could not be substantiated, as the device was not returned for evaluation.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.

• 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: 23691585
• Report Number: 9616099-2025-01921
• Device Sequence Number: 21102904
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)280430(10)18456348
• 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): 01/22/2026

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 Model Number: N/A
• Device Catalogue Number: 451514H0
• Device Lot Number: 18456348
• Was Device Available for Evaluation?: Yes
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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: ANOTHER UNKNOWN DEVICE.
• Patient Age: 87 YR
• Patient Sex: Male