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

Catalog Number 534621T

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during a coronary angiography, the connector of a 6f 100cm judkins right (jr) 4 infiniti diagnostic catheter ¿did not match the triple tee plate¿ which resulted in an inability to ensure the sealing of fluid during the angiography.As a result, an unknown device was used as a replacement.There was no reported injury to the patient and the device will not be returned for evaluation.The hospital reported it as an adverse event to the china nmpa directly.The device will not be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, during a coronary angiography, the connector of a 6f 100cm judkins right (jr) 4 infiniti diagnostic catheter ¿did not match the triple tee plate¿ which resulted in an inability to ensure the sealing of fluid during the angiography.As a result, an unknown device was used as a replacement.There was no reported injury to the patient and the device will not be returned for evaluation.The device was not returned for analysis.A review of the manufacturing documentation associated with lot 10106175 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿luer hub - catheters ¿ incompatibility/fit¿ could not be confirmed or further clarified without the return of the device and concomitant product.As such a definitive cause for the event could not be determined, however, handling factors and/or issues with the ¿triple tee plate¿ may have contributed to the reported 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, ¿before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ if the device cannot be connected to another device for flushing of the catheter it should not be used.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, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16702881
• MDR Text Key: 313006147
• Report Number: 9616099-2023-06461
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014199
• UDI-Public: (01)10705032014199(17)250731(10)18138027
• 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: 05/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 534621T
• Device Lot Number: 18138027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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