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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the cap at the top of a 4f cobra (c) 1 65cm tempo diagnostic catheter was broken when a syringe was attached, which caused leaking.There was no reported patient injury.As far as the operator is aware, there was not any excess pressure used which could have caused the issue.Additional information was requested but not provided.The device was not returned as expected.
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
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.A review of the manufacturing documentation associated with lot 18352156 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.Complaint conclusion: as reported, the cap at the top of a 4f cobra (c) 1 65cm tempo diagnostic catheter was broken when a syringe was attached, which caused leaking.There was no reported patient injury.As far as the operator is aware, there was not any excess pressure used which could have caused the issue.Additional information was requested but not provided.A non-sterile cath tempo 4f c1 65cm 2sh catheter was received coiled inside a clear plastic bag and unpacked for evaluation.During visual inspection, no damage or anomalies were seen with the naked eye on the returned device components; however, due to the reported event, amplified imaging of the hub was performed, which revealed a cracked condition.Detailed analysis of the cracked hub area found fatigue striations commonly associated with tensile overload, indicating that the plastic material had been subjected to a tensile force exceeding the hub component¿s yield strength prior to the observed damage.A product history record (phr) review of lot 18352156 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub ¿ cracked¿ was seen during the product evaluation.The exact cause of the reported event cannot be found.The damages occurred while attaching a syringe and evaluation results showed signs of tensile overload therefore, handling factors cannot be excluded.As stated in the device labeling, the device is intended for use by trained professionals, and no evidence was identified to suggest a manufacturing-related contribution to the observed condition.Therefore, no additional actions will be taken 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: 24293829
• Report Number: 9616099-2026-00224
• Device Sequence Number: 10213134
• Product Code: DQO
• UDI-Device Identifier: 10705032008037
• UDI-Public: (01)10705032008037(17)270731(10)18352156
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 451442V2
• Device Lot Number: 18352156
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 04/07/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/02/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: UNKNOWN.
• Patient Sex: Unknown