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

Catalog Number	451532H0
Medical Device Problem Codes	Crack (1135); Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the distal portion at the curve of a 5f 100 cm tempo coronary guiding catheter was observed to have a crack upon opening the package and subsequently broke when examined.The device was not used, and another tempo product was selected.There was no reported patient injury.The nurse and physician noted that the catheter felt very dry, and similar findings were observed with three catheters from two different batches, while a catheter from another batch was found to be intact.The products were properly stored and opened in sterile field.No device damage was observed prior to opening the package, and no difficulty was encountered in removing the device from its sterile packaging.The device was prepped according to the instructions for use (ifu), and no issues were experienced during preparation.Two images were provided showing a crack at the distal portion of the catheter.The devices will be returned for evaluation.
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 distal portion at the curve of a 5f 100 cm tempo coronary guiding catheter was observed to have a crack upon opening the package and subsequently broke when examined.The device was not used, and another tempo product was selected.There was no reported patient injury.The nurse and physician noted that the catheter felt very dry, and similar findings were observed with three catheters from two different batches, while a catheter from another batch was found to be intact.The products were properly stored and opened in sterile field.No device damage was observed prior to opening the package, and no difficulty was encountered in removing the device from its sterile packaging.The device was prepped according to the instructions for use (ifu), and no issues were experienced during preparation.Two images were provided showing a crack at the distal portion of the catheter.The devices were returned for evaluation.

• 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: 24201070
• Report Number: 9616099-2026-00152
• Device Sequence Number: 5509171
• Product Code: DQO
• UDI-Device Identifier: 10705032008600
• UDI-Public: (01)10705032008600(17)270131(10)18287039
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 451532H0
• Device Lot Number: 18287039
• 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: 01/01/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 03/30/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/11/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2024
• 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
• Patient Sex: Unknown