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

Catalog Number	534620T
Medical Device Problem Codes	Crack (1135); Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the distal tip of the 6f 100 cm infiniti judkins left (jl4) diagnostic catheter was found cracked when the product was opened.The product was not used in the patient.Another unknown catheter was used to complete the coronary angiography procedure.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.The device was returned for evaluation.
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
As reported, the distal tip of the 6f 100 cm infiniti judkins left (jl4) diagnostic catheter was found cracked when the product was opened.The product was not used in the patient.Another unknown catheter was used to complete the coronary angiography procedure.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no device damage noticed prior to opening the package or difficulty removing the device from the sterile packaging.A non-sterile unit of ¿cath f6inf tl jl 4 100cm¿ was received for analysis.The unit presented with a frayed condition located approximately 9 cm from the distal tip.No other outstanding details were observed.Sem analysis was not performed because the damages associated with the separation are visible with the magnification obtained with a vision system.The frayed edges were inspecting with the vision system and evidence of elongations, fatigue lines, and plastic deformation because of a twisted tension applied to the device material were noted.These characteristics found on the materials of the unit are commonly associated with damages caused by material tensile/twist overload.Therefore, it is assumed that the material was induced to a tensile/twist forces that exceeded the material yield strength prior to the frayed condition.The reported ¿brite tip/distal tip~cracked¿ was not confirmed because a cracked condition was not observed on the distal tip.However, the event ¿brite tip/distal tip~ frayed/split/torn¿ was confirmed.The distal tip presented with a frayed condition.The exact cause of this damage could not be conclusively determined during the analysis.It is assumed that the material was induced to a tensile/twist force that exceeded the material yield strength prior to the damage.Handling factors such as removing the catheter from the mounting card by pulling on the distal tip is a possible cause.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.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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
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: 19433872
• Report Number: 9616099-2024-00174
• Device Sequence Number: 8322216
• Product Code: DQO
• UDI-Device Identifier: 10705032014182
• UDI-Public: (01)10705032014182(17)270131(10)18291200
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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: 534620T
• Device Lot Number: 18291200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/28/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/28/2024
• Date Device Manufactured: 03/01/2024
• 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.
• Patient Sex: Unknown