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
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 is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
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.
Additional Manufacturer Narrative
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.Three devices were returned and evaluated under complaints (b)(4).(b)(4): a non-sterile cath tempo 5f sim 3 100cm device involved in the reported complaint was returned for investigation.Visual inspection showed the catheter body was in a severely cracked condition, with extensive cracking distributed throughout its full length, and the device was received separated into two parts.During visual inspection, the strain relief was received complete and was also inspected, with no damage observed in that area.No additional anomalies were detected during the visual examination.Dimensional evaluation of the internal and external diameters could not be performed because the severely cracked condition throughout the catheter body prevented accurate measurement.High-magnification evaluation was performed to verify the condition identified during visual analysis and to further assess the strain relief and hub.Upon closer examination, the catheter body exhibited a severely cracked condition with extensive cracking noted along its length, consistent with the visual findings.The strain relief was also evaluated under magnification, and no abnormal conditions or damage were observed.Additionally, the hub presented small scratches.The received unit presented conditions related to degradation.Product evaluation confirmed that the catheter body had a severely cracked condition characterized by multiple cracks distributed extensively along its full length and that the device was received separated into two parts.Microscopic evaluation confirmed the cracking previously identified during visual inspection, while the hub presented small scratches and the strain relief did not present any abnormal conditions.The reported ¿brite tip/distal tip ¿ cracked¿ was not seen on the returned devices.However, the malfunctions ¿catheter (body/shaft) ¿ degradation¿ and ¿brite tip/distal tip ¿ cracked¿ and ¿catheter (body/shaft) ¿ separated¿ were seen on the device associated with complaint (b)(4).The exact cause of the degradation could not be determined.Users are trained to inspect products for signs of damage prior to and during use, and any product showing damage is not to be used.The product labeling includes information for safety intended to make users aware of such risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not expose to organic solvents.¿ while this guidance mitigates risks associated with storage and handling, it does not eliminate the potential for degradation.An investigation is ongoing to further evaluate degradation.

• 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: 24201092
• Report Number: 9616099-2026-00153
• Device Sequence Number: 5507968
• Product Code: DQO
• UDI-Device Identifier: 10705032008600
• UDI-Public: (01)10705032008600
• 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
• 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
• 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