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	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the end of the 5f 100 cm tempo vertebral (vert) catheter was found broken and chipped when the instrumentation nurse opened the contrast catheter during the procedure and another tempo catheter was used to complete the procedure.There was no reported patient injury.The device was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.Three (3) pictures were received for review.Two of them show the package labeling.The third image shows a luer hub, which appears to have a splintered condition on the proximal side of the component.A non-sterile catheter ¿cath tempo 5f ver 135° 100cm¿ was received for analysis.During visual inspection, a splintered condition and a cracked line were observed on the hub.Sem analysis was not performed because the damages associated with the crack are visible with the magnification obtained with a vision system.The cracked and splintered area on the hub presented evidence fatigue striations.Fatigue striations found on the hub material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the cracked and splintered.The complaint reported by the customer as ¿luer hub~ splintered¿ was confirmed, a splintered condition and a cracked condition was observed on the luer hub.The exact cause of the observed damage could not be conclusively determined during the analysis.It is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the cracked and splintered.Procedural, storage, or handling factors may have contributed to the failure as reported.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 products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54° c (130o f) may damage the catheter,¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.
Event or Problem Description
As reported, the end of the 5f 100 cm tempo vertebral (vert) catheter was found broken and chipped when the instrumentation nurse opened the contrast catheter during the procedure and another tempo catheter was used to complete the procedure.There was no reported patient injury.The device was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.Three (3) pictures were received for review.Two of them show the package labeling.The third image shows a luer hub, which appears to have a splintered condition on the proximal side of the component.The device was returned for evaluation.The unit was inspected focusing on the luer hub area observing a splintered condition and a cracked line.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 20158497
• Report Number: 9616099-2024-00298
• Device Sequence Number: 11824082
• Product Code: DQO
• UDI-Device Identifier: 10705032008464
• UDI-Public: (01)10705032008464(17)261130(10)18267914
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

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: 18267914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• 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: 08/28/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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: CORDIS TUBE, TERUMO SHEATH
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 76 KG