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

Catalog Number 534618T

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  malfunction  

Event Description

As reported, a 6f infiniti jk3.5 100cm guiding catheter was found damaged when the package was opened.The plastic part of hub of the catheter was broken and missing.It was not the catheter body.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The intended procedure was diagnostic.The target site was the coronary artery.The device was stored and prepped per the instructions for use (ifu).The user is trained to the device.The vessel at the target site had mild calcification, mild tortuosity, no acute or bifurcating angle.The vessel had a stenosis of 90%.The device was not being used for treatment of a chronic total occlusion (cto).The device will be returned for evaluation.

Manufacturer Narrative

-a review of the manufacturing documentation associated with lot 18040919 presented no issues during the manufacturing process that can be related to the reported event.-this device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.-additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a 6f infiniti jk3.5 100cm guiding catheter was found damaged when the package was opened.The plastic part of hub of the catheter was broken and missing.It was not the catheter body.There was no reported patient injury.The intended procedure was diagnostic.The target site was the coronary artery.The device was stored and prepped per the instructions for use (ifu).The user is trained to the device.The vessel at the target site had mild calcification, mild tortuosity, no acute or bifurcating angle.The vessel had a stenosis of 90%.The device was not being used for treatment of a chronic total occlusion (cto).A non- sterile ¿cath f6 inf tl jl 3.5 100 cm" was received for evaluation.During visual inspection, the luer hub presented with a fractured/separated condition.The separated piece was not retuned for analysis.No other damages or anomalies were observed during visual analysis.Sem analysis presented evidence of fatigue striation patterns along the luer hub.A product history record (phr) review of lot 18040919 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿luer hub~separated¿ was confirmed.The returned unit presented with a separated condition on the luer hub.Fatigue striation patterns are commonly associated with fractures caused in polymeric materials where stress force resistance properties are overloaded.The exact source of the excessive stress placed on the luer hub could not be determined during the analysis however, storage and/or handling factors are a likely 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.Do not use if package is open or damaged.¿ based on the information available and the phr review, 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.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17583744
• MDR Text Key: 321530326
• Report Number: 9616099-2023-06578
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014168
• UDI-Public: (01)10705032014168(17)240630(10)18040919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 534618T
• Device Lot Number: 18040919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.