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

Catalog Number	534620T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during the procedure, the tip of a 6f 100cm judkin's left (jl) 4 infiniti diagnostic catheter became dislodged.The device was found to be defective after inserting into patient.Second groin access to the left femoral artery was obtained.The physician snared the loose piece out of the patient's body successfully.There were no reports of patient injury.The patient is a middle-aged female with a past medical history of hypertension, hyperlipidemia, diabetes who presents to the cardiac catheterization lab with canadian class iii angina despite optimal medical therapy.Diagnostic findings revealed: there was 30% stenosis of the mid left anterior descending artery (lad), which is associated with myocardial bridge; there was a patent stent in the proximal lad; there was a patent left main; there was mild diffuse disease in the left circumflex, there was 40% stenosis of the distal right coronary artery (rca).The device will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h10.Complaint conclusion: as reported, during the procedure, the tip of a 6f 100cm judkin's left (jl) 4 infiniti diagnostic catheter became dislodged.The device was found to be defective after inserting into patient.Second groin access to the left femoral artery was obtained.The physician snared the loose piece out of the patient's body successfully.There were no reports of patient injury.The patient is a middle-aged female with a past medical history of hypertension, hyperlipidemia, diabetes who presents to the cardiac catheterization lab with canadian class iii angina despite optimal medical therapy.Diagnostic findings revealed: there was 30% stenosis of the mid left anterior descending artery (lad), which is associated with myocardial bridge; there was a patent stent in the proximal lad; there was a patent left main; there was mild diffuse disease in the left circumflex, there was 40% stenosis of the distal right coronary artery (rca).The device was not returned for evaluation.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip-separated¿ could not be confirmed.Procedural or 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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ 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 preventative 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 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 ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 19559951
• Report Number: 9616099-2024-00203
• Device Sequence Number: 6805971
• Product Code: DQO
• UDI-Device Identifier: 10705032014182
• UDI-Public: (01)10705032014182(17)251031(10)18165758
• 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: Non-Healthcare 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 534620T
• Device Lot Number: 18165758
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/23/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Race: Black Or African American