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	Foreign Body In Patient (2687)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of a 5f tempo vertebral (vert) 100 cm diagnostic catheter was found broken in the patient¿s distal internal carotid artery (ica) during mid-use.No anomalies were noted when the device was removed from the package or during preparation.No resistance was met while advancing the device, no excessive torqueing was required, and no resistance was encountered while advancing the device over the guidewire.The device did not kink in the area of separation.No resistance was met while withdrawing the device; however, the distal tip broke, and although there was no kink in the area of separation, the user had to snare it out with difficulty.The event occurred during a diagnostic cerebral angiogram; the vessel was not tortuous and the catheter was not kinked.The lesion was not calcified, and the device was used for a diagnostic cerebral angiogram.The device was not used for a chronic total occlusion (cto).The patient remained stable, though the process was prolonged due to retrieval difficulty.The user is trained to the device.The device was properly stored and opened in a sterile field.Other procedural details were requested but were not provided.The device will be returned for evaluation.
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.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the tip of a 5f tempo vertebral (vert) 100 cm diagnostic catheter was found broken in the patient¿s distal internal carotid artery (ica) during mid-use.No anomalies were noted when the device was removed from the package or during preparation.No resistance was met while advancing the device, no excessive torquing was required, and no resistance was encountered while advancing the device over the guidewire.The device did not kink in the area of separation.No resistance was met while withdrawing the device; however, the distal tip broke, and although there was no kink in the area of separation, the user had to snare it out with difficulty.The event occurred during a diagnostic cerebral angiogram; the vessel was not tortuous, and the catheter was not kinked.The lesion was not calcified, and the device was used for a diagnostic cerebral angiogram.The device was not used for a chronic total occlusion (cto).The patient remained stable, though the process was prolonged due to retrieval difficulty.The user is trained to the device.The device was properly stored and opened in a sterile field.The device was resterilized after the procedure.Other procedural details were requested but were not provided.The diagnostic catheter was visually evaluated based on one photo provided for review.The image shows a separation at the proximal section of the brite tip, with an irregular separation edge observed on the larger portion of the unit.No additional observable details or distinguishing features were identified in the image.The available visual information is insufficient to determine whether the observed condition is related to a manufacturing or design issue, and no definitive conclusions can be drawn based on the material provided.The reported ¿brite tip/distal tip ¿ separated¿ was observed during the photo analysis however, the root cause cannot be determined.The device was reported to have been used without resistance, excessive torque, kinking, or advancement difficulty, and the anatomy was described as non-tortuous and non-calcified.However, the distal tip separated during withdrawal and required snare retrieval.Given the absence of complete procedural details and the lack of returned product for further evaluation, use-related factors cannot be excluded.The instructions for use (ifu) state: ¿this product is intended for use by professionals who have been trained to perform diagnostic and interventional catheterization procedures.¿ based on the available information, there is no evidence to suggest the reported event is related to the device design or manufacturing process.Therefore, no additional actions will be taken.

• 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: 24428031
• Report Number: 9616099-2026-00301
• Device Sequence Number: 9904896
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)280131(10)18421098
• 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): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 451514H0
• Device Lot Number: 18421098
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2025
• 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: SNARE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female