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

Catalog Number 538418

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, disconnection of the infiniti f4 jl3.5 tip from the rest of the medical device, resulting in embolization in the distal circumflex artery.The embolization was performed in the "correct direction", without blocking blood flow.The endothelialization process should the tip, but the risk of myocardial infarction (mi) is not negligible.The tip has not been removed.The risk/benefit ratio of tip removal is poor.In fact, its recovery could displace it.No immediate consequences to the patient, but possibility of mi or stroke if tip migrates.The patient was placed on long term medicine therapy.Additional information was requested; however, the information was not obtained after multiple attempts.

Event Description

As reported, disconnection of the infiniti f4 jl3.5 tip from the rest of the medical device, resulting in embolization in the distal circumflex artery.The embolization was performed in the "correct direction", without blocking blood flow.The endothelialization process should the tip, but the risk of myocardial infarction (mi) is not negligible.The tip has not been removed.The risk/benefit ratio of tip removal is poor.In fact, its recovery could displace it.No immediate consequences to the patient, but possibility of mi or stroke if tip migrates.The patient was placed on long term medicine therapy.Additional information was requested; however, the information was not obtained after multiple attempts.

Manufacturer Narrative

As reported, disconnection of the infiniti f4 jl3.5 tip from the rest of the medical device, resulting in embolization in the distal circumflex artery.The embolization was performed in the "correct direction", without blocking blood flow.The endothelialization process should secure the tip, but the risk of myocardial infarction (mi) is not negligible.The tip has not been removed.The risk/benefit ratio of tip removal is poor.In fact, its recovery could displace it.No immediate consequences to the patient, but possibility of mi or stroke if tip migrates.The patient was placed on long term medicine therapy.The device was not returned for analysis.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip-separated¿ could not be confirmed.Handling factors 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, "to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation." based on the available information, 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 US. CORP; 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 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 19214597
• MDR Text Key: 341458160
• Report Number: 9616099-2024-00134
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014588
• UDI-Public: 10705032014588
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 538418
• Device Lot Number: 18269271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Device Manufactured: 12/19/2023
• 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
• Patient Outcome(s): Life Threatening; Other