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

Catalog Number	534518T
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a foreign substance was found inside the packaging of the contrast tube of a 5f judkins left (jl) infiniti diagnostic catheter.The issue was found after delivering the goods to the hospital, when it was ready to be delivered to the operating room after unpacking the outer packaging in the equipment section.The device did not meet the sterility standards.The product was not used in the patient.There was no reported patient injury.The product is expected to be returned for investigation.
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.
Additional Manufacturer Narrative
As reported, a foreign substance was found inside the packaging of the contrast tube of a 5f judkins left (jl) infiniti diagnostic catheter.The issue was found after delivering the goods to the hospital, when it was ready to be delivered to the operating room after unpacking the outer packaging in the equipment section.The device did not meet the sterility standards.The product was not used in the patient.There was no reported patient injury.A sterile unit cath f5 inf jl 3.5 100cm guiding catheter was received in its sealed sterile pouch.During visual analysis, the identification of the reported foreign material on the unit¿s body/shaft was not confirmed.However, some particles were observed on the external surface of the sealed sterile pouch.There is no evidence of a compromised seal as the pouch was received closed and sealed.The foreign material observed was measured using a pocket compare with the acceptance parameter found within specification.The foreign particles were easily removed from the external surface of the pouch showing that the internal (sterile) portion of the bag was not compromised.A high magnification visual evaluation was done looking for foreign material on the body/shaft of the returned device and the presence of foreign material on the body/shaft of the unit was not confirmed.The reported ¿catheter (body/shaft) foreign material¿ was not confirmed.Foreign material was not observed on the returned device.It was located outside of the sealed sterile pouch bag and the sterile barrier was not compromised.The exact cause of the reported event could not be determined however, foreign material may have landed on the outside of the sealed sterile pouch while in storage.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.
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: INFINITI
• 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 ; 7863138372
• MDR Report Key: 18727156
• Report Number: 9616099-2024-00057
• Device Sequence Number: 5741054
• Product Code: DQO
• UDI-Device Identifier: 10705032013666
• UDI-Public: (01)10705032013666(17)260831(10)18244957
• 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,Followup,Followup
• Report Date (Section B): 08/15/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 534518T
• Device Lot Number: 18244957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 03/01/2024; 04/23/2024; 08/15/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/01/2024; 04/26/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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: UNKNOWN.
• Patient Sex: Unknown