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

Catalog Number	534521T
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a hole was found midway down a 5f 100 cm infiniti judkins right (jr4) diagnostic catheter when opened.The packaging was intact.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).An angiography was reported to be the intended procedure.The device 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 hole was found midway down a 5f 100 cm infiniti judkins right (jr4) diagnostic catheter when opened.The packaging was intact.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).The intended procedure was an angiogram.One non-sterile cath f5 inf jr 4 100cm catheter was received for analysis.During visual inspection, no punctures or kinked/bent sections were observed on the received device.The device was inspected for damages/anomalies that may have contributed to the reported failure and none were observed.Visual inspection at high magnification confirmed the absence of punctures or kinked/bent on the catheter or the distal tip.The reported "catheter (body/shaft)-puncture/cut" was not confirmed.No damages were found on the returned device and the exact cause of the reported event could not be determined.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 preventive 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, 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: 18501508
• Report Number: 9616099-2024-00013
• Device Sequence Number: 8125502
• Product Code: DQO
• UDI-Device Identifier: 10705032013697
• UDI-Public: (01)10705032013697(17)260831(10)18241668
• 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: 534521T
• Device Lot Number: 18241668
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 02/01/2024; 03/11/2024; 08/15/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/13/2024; 03/16/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: (B)(6) 2023.
• Patient Sex: Unknown