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

Catalog Number	451530H0
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
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, during the cerebral angiography procedure for the patient, it was found that the end of the 5f cordis sim1 tempo contrast catheter was broken and leaked when it was connected to the syringe to push the contrast medium.The doctor connected to the syringe, then sprayed all over with the water there was no reported injury to the patient.The device will not be returned for evaluation as it was discarded and not available for testing.The hospital reported it as an adverse event to the china nmpa directly.
Additional Manufacturer Narrative
As reported, during the cerebral angiography procedure for the patient, it was found that the end of the 5f cordis sim1 tempo contrast catheter was broken and leaked when it was connected to the syringe to push the contrast medium.The doctor connected to the syringe, then contrast media sprayed all over the operator.There was no reported injury to the patient.Without the return of the device or images for analysis, the reported customer events ¿luer hub-leakage¿ and ¿luer hub-damaged¿ could not be confirmed.Handling factors such as overtightening the syringe to the luer may have contributed to the reported event.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.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, during the cerebral angiography procedure for the patient, it was found that the end of the 5f cordis sim1 tempo contrast catheter was broken and leaked when it was connected to the syringe to push the contrast medium.The doctor connected to the syringe, then contrast media sprayed all over the operator.There was no reported injury to the patient.The device will not be returned for evaluation as it was discarded and not available for testing.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• 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: 19352714
• Report Number: 9616099-2024-00161
• Device Sequence Number: 17949957
• Product Code: DQO
• UDI-Device Identifier: 10705032008563
• UDI-Public: (01)10705032008563(17)260930(10)18250143
• 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): 08/27/2024

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
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 451530H0
• Device Lot Number: 18250143
• Was Device Available for Evaluation?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/27/2024; 08/27/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/17/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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
• Patient Sex: Unknown