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

Catalog Number	451506P0
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	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation; however, the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the tip of a 5f tempo multipurpose (mpa) 125cm diagnostic catheter was "fractured".The fractured catheter remained outside the long sheath but did not completely detach from the guidewire tip.The operator secured the guidewire tip with a grasping device, then retracted the fractured catheter back into the long sheath before removing the entire assembly from the body.There was no reported patient injury.Additional event details were requested; however, not provided.The device was returned for analysis.One radiographic image was submitted, and it shows what appears to be a guidewire, sheath the distal tip of a catheter and they are seen traversing anterior to the vertebral column and curving upward toward the skull base.The distal tip of the catheter separated from its proximal portion.
Additional Manufacturer Narrative
As reported, the tip of a 5f tempo multipurpose (mpa) 125cm diagnostic catheter was "fractured".The fractured catheter remained outside the long sheath but did not completely detach from the guidewire tip.The operator secured the guidewire tip with a grasping device, then retracted the fractured catheter back into the long sheath before removing the entire assembly from the body.There was no reported patient injury.Additional event details were requested; however, not provided.The device was returned for analysis.One radiographic image was submitted, and it shows what appears to be a guidewire, distal portion of the long sheath and the distal tip of a catheter.They are seen traversing anterior to the vertebral column and curving upward toward the skull base.The distal tip of the catheter separated from its proximal portion.Cath tempo 5f mp a1 (i), 125 cm: a non-sterile unit was received coiled in a transparent plastic bag and unpacked for evaluation.Visual inspection identified separation of the distal tip from the catheter body, with no additional damage or anomalies observed on the returned components without magnification.Dimensional analysis was performed in the area adjacent to the separation to verify the catheter inner and outer diameters against applicable specifications; measurements of the outer diameter at 1 cm from the distal end and the inner diameter at the same location were obtained using calibrated measuring equipment and were confirmed to be within specification.Microscopic evaluation of the separated area identified evidence of plastic material elongation, a characteristic finding associated with exposure to excessive tensile stress in which the material is stretched beyond its elastic limit, indicating that the distal tip was subjected to a tensile load exceeding the yield strength of the component prior to separation.The fusion interface between the catheter body and distal tip was observed to be intact and in acceptable condition.No evidence of manufacturing defects or assembly-related issues was identified, and based on the available information and product analysis, the reported failure is not considered to be related to the manufacturing process.The reported ¿brite tip/distal tip ¿ separated¿ was found during the product evaluation.The exact cause of the separation cannot be found.Microscopic evaluation of the separated area identified evidence of plastic material elongation, a characteristic finding associated with exposure to excessive tensile stress in which the material is stretched beyond its elastic limit, indicating that the distal tip was subjected to a tensile load exceeding the yield strength of the component prior to separation.Therefore, procedural or handling factors cannot be excluded as a potential root cause.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the product labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.To prevent kinking of 5f (1.65 mm) and smaller diagnostic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi).¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014 2802
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 23555188
• Report Number: 9616099-2025-01839
• Device Sequence Number: 10107570
• Product Code: DQO
• UDI-Device Identifier: 10705032008358
• UDI-Public: (01)10705032008358(17)270131(10)18290488
• 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): 01/13/2026

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 Catalogue Number: 451506P0
• Device Lot Number: 18290488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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: YIXINDA 5F SHEATH.
• Patient Sex: Unknown