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

Catalog Number	451514H0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
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 crack was present on the hub of a 5f ver 135° 100cm tempo diagnostic catheter.There was no reported patient injury.The hospital reported this case as an adverse event to the china nmpa.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, a crack was present on the hub of a 5f ver 135° 100cm tempo diagnostic catheter.There was no reported patient injury.The hospital reported this case as an adverse event to the china nmpa.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.A non-sterile cath tempo 5f ver 135° 100cm catheter was received coiled inside a clear plastic bag and was unpacked for evaluation.Inspection of the unit identified a cracked line at the luer hub and a kinked condition on the catheter body located approximately 74 cm from the distal tip, with no other notable observations.Dimensional analysis was performed to verify the outer and inner diameters of the catheter, with measurements taken near the kinked area, and all results were found to be within specification.Examination of the cracked luer hub using a vision system identified fatigue striations on the cracked surface, which are commonly associated with separations resulting from material tensile overload, indicating the hub material had been subjected to a tensile force exceeding its material strength prior to cracking.Although these observations were documented, the exact cause of the observed conditions could not be conclusively determined during the evaluation, and the product analysis did not provide evidence suggesting the reported event was related to the manufacturing or design process.The reported ¿luer hub ¿ cracked¿ was seen during the product evaluation.The exact cause of the event cannot be found; however, the signs of mechanical interaction or stress noted during the product evaluation indicate procedural factors may be a contributing factor.Information for safety is provided in the product¿s labeling with the intent of making the user aware of the risks.The current device labeling does not include specific warnings regarding user¿s experience.The event is consistent with localized mechanical stress, potentially related to handling factors such as over-tightening or external compression.Prevention of such occurrences is addressed through operator training and adherence to standard interventional practice.The labeling includes a precaution stating that the device is intended for use only by physicians trained and experienced in diagnostic and interventional catheterization techniques.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.; 14021 nw 60 avenue; miami lakes, florida 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: 23507087
• Report Number: 9616099-2025-01792
• Device Sequence Number: 15738382
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)280430(10)18456347
• 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): 12/19/2025

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 Catalogue Number: 451514H0
• Device Lot Number: 18456347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/09/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 60 YR
• Patient Sex: Female