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

Catalog Number 538421

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18131652 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.

Event Description

As reported, the tip of a 4f judkins right jr 4 100cm infiniti diagnostic catheter was found cracked during the procedure.There were no reports of patient injury.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the tip of a 4f judkin's right (jr) 4 100cm infiniti diagnostic catheter was found cracked during the procedure.There were no reports of patient injury.One non-sterile unit of diagnostic catheter (cath 4f inf 100cm jr4) was received for evaluation.During visual inspection, the hub was found to be broken.No other anomalies were observed.The fusion area of the catheter was observed under the vision system and no anomalies were found.Sem analysis was performed to determine the root cause of the separation to the luer hub.The analysis showed striation patterns along the luer hub proximal end.A product history record (phr) review of lot 18131652 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 ¿brite tip/distal tip-cracked¿ was not confirmed.No anomalies were observed at the fusion area or on the tip of the catheter.The event "luer hub-separated¿ was confirmed.A separation was found on the hub.The exact cause of the separation cannot be conclusively determined however, striation patterns are commonly associated with separations caused by material overload.Therefore, it is assumed that the material was induced to forces that exceeded the material yield strength prior to the separation.Storage and/or handling factors are likely causes of the 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, ¿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.

Manufacturer Narrative

An updated review of the manufacturing documentation associated with lot 18131652 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

-after further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, h3, h6, and h10 -this device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.-additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16731560
• MDR Text Key: 313210925
• Report Number: 9616099-2023-06467
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014618
• UDI-Public: (01)10705032014618(17)250630(10)18131652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862244
• 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,Followup,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 538421
• Device Lot Number: 18131652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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.