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	10/15/2024
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, while the patient was having an aortogram procedure, contrast medium leaked through the connection that goes to the catheter of the injector extension of the 65 cm catheter extension tubing.The damage was noticed at the time of the contrast medium injection.It leaked at a female connection point and it was changed for another extension which had the same problem.Another cordis extension was passed and it worked without any problem.The procedure was carried out without any further complications and the patient left in perfect condition.There was no reported patient injury.There were no damages noted to the devices.The devices are expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, while the patient was having an aortogram procedure, contrast medium leaked through the connection that goes to the catheter of the injector extension of the 65 cm catheter extension tubing.The damage was noticed at the time of the contrast medium injection.It leaked at a female connection point and it was changed for another extension which had the same problem.Another cordis extension was passed and it worked without any problem.The procedure was carried out without any further complications and the patient left in perfect condition.There was no reported patient injury.There were no damages noted to the devices.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.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 preventative or corrective actions will be taken at this time.
Event or Problem Description
The device was not returned for evaluation as anticipated.

• 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: 20609553
• Report Number: 9616099-2024-00362
• Device Sequence Number: 7393275
• Product Code: DQO
• UDI-Device Identifier: 10705032064712
• UDI-Public: (01)10705032064712(17)261130(10)18268994
• 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): 11/15/2024

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: 18268994
• Was Device Available for Evaluation?: Yes
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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: N/A.
• Patient Sex: Female