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

Catalog Number	502101D
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During aortogram procedures in (b)(6) laboratories, when using the 65 cm catheter extension tubing for the injector, it did not work properly, causing a leak of contrast medium, when connecting it to the injector and starting to inject.This required the use of a second device that had the same fault.The situation was corrected by using a third device, which worked correctly, without causing any harm to the patient.There was no device damage noted.The devices are expected to 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.
Event or Problem Description
The devices were not returned for evaluation as anticipated.
Additional Manufacturer Narrative
During aortogram procedures in hemodynamic laboratories, when using the 65 cm catheter extension tubing for the injector, it did not work properly, causing a leak of contrast medium, when connecting it to the injector and starting to inject.This required the use of a second device that had the same fault.The situation was corrected by using a third device, which worked correctly, without causing any harm to the patient.There was no device damage noted.The devices were not returned for evaluation as anticipated.Without the return of the device or images for analysis, the reported customer event ¿catheter extension tubing-leakage¿ could not be confirmed for either device.Shipping/handling factors 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, ¿to prevent damage, withdraw the catheter extension gently.Rapid removal or jerking may damage the extension.¿ 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.

• Brand Name: CATHETER EXTENSION
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 20125283
• Report Number: 9616099-2024-00289
• Device Sequence Number: 7417764
• Product Code: DQO
• UDI-Device Identifier: 10705032064712
• UDI-Public: (01)10705032064712(17)261130(10)18266536
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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
• Report Date (Section B): 09/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 502101D
• Device Lot Number: 18266536
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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