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

Catalog Number	451431H0
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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, when using a 4f 100cm sidewinder simmons 2 (sim2) tempo diagnostic catheter to perform an angiogram in the superficial femoral artery (sfa), the device was connected to an unknown y-valve and liquid leakage was found at the connection.This ¿triggered extravasation of the contrast agent when it was injected into the contrast medium¿ with a high-pressure contrast injector, which affected the quality of the image.Additionally, large amounts of liquid seepage were observed, affecting the aseptic environment.Extravasation, defined as a leakage of a solution out of the vessel and into the surrounding tissue of the patient, did not occur.However, the term ¿extravasation¿ was used to describe an excess leakage of contrast solution coming from the luer hub connection, outside of the patient.The procedure was completed by changing to a new unknown catheter.There were no reported injuries to the patient and the patient was in good status post-procedure.The device was stored and prepped per the instructions for use (ifu).There was no damage to the luer hub of the 4f sim2 tempo catheter, and there was no difficulty connecting the y-valve to the luer hub of the 4f sim2 tempo catheter.The device will be returned for evaluation.The hospital reported this case as an adverse event to the china nmpa directly.
Additional Manufacturer Narrative
After further review of additional information received: complaint conclusion: as reported, when using a 4f 100cm sidewinder simmons 2 (sim2) tempo diagnostic catheter to perform an angiogram in the superficial femoral artery (sfa), the device was connected to an unknown y-valve and liquid leakage was found at the connection.This ¿triggered extravasation of the contrast agent when it was injected into the contrast medium¿ with a high-pressure contrast injector, which affected the quality of the image.Additionally, large amounts of liquid seepage were observed, affecting the aseptic environment.Extravasation, defined as a leakage of a solution out of the vessel and into the surrounding tissue of the patient, did not occur.However, the term ¿extravasation¿ was used to describe an excess leakage of contrast solution coming from the luer hub connection, outside of the patient.The procedure was completed by changing to a new unknown catheter.There were no reported injuries to the patient and the patient was in good status post-procedure.The device was stored and prepped per the instructions for use (ifu).There was no damage to the luer hub of the 4f sim2 tempo catheter, and there was no difficulty connecting the y-valve to the luer hub of the 4f sim2 tempo catheter.Without the return of the device or images for analysis, the reported customer event of ¿luer hub-leakage¿ 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, when using a 4f 100cm sidewinder simmons 2 (sim2) tempo diagnostic catheter to perform an angiogram in the superficial femoral artery (sfa), the device was connected to an unknown y-valve and liquid leakage was found at the connection.This ¿triggered extravasation of the contrast agent when it was injected into the contrast medium¿ with a high-pressure contrast injector, which affected the quality of the image.Additionally, large amounts of liquid seepage were observed, affecting the aseptic environment.Extravasation, defined as a leakage of a solution out of the vessel and into the surrounding tissue of the patient, did not occur.However, the term ¿extravasation¿ was used to describe an excess leakage of contrast solution coming from the luer hub connection, outside of the patient.The procedure was completed by changing to a new unknown catheter.There were no reported injuries to the patient and the patient was in good status post-procedure.The device was stored and prepped per the instructions for use (ifu).There was no damage to the luer hub of the 4f sim2 tempo catheter, and there was no difficulty connecting the y-valve to the luer hub of the 4f sim2 tempo catheter.The device was not returned as expected.The hospital reported this case as an adverse event to the china nmpa directly.

• 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: 20795557
• Report Number: 9616099-2024-00442
• Device Sequence Number: 7808644
• Product Code: DQO
• UDI-Device Identifier: 10705032007948
• UDI-Public: (01)10705032007948(17)270531(10)18332938
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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 Catalogue Number: 451431H0
• Device Lot Number: 18332938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• 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 CATHETER.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 59 KG