MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6 INFINITI TL JR 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534621T
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	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number is unknown; if received it will be provided.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a piece of the tip of a 6f judkins right 4 100cm infiniti diagnostic catheter broke off in the patient's radial artery during a cardiac cath while visualizing the coronary arteries.This resulted in the patient needing a follow up surgery to remove the tip and was removed successfully.There was no reported patient injury.The product was properly stored and opened in sterile field.The user was trained to the device.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a piece of the tip of a 6f judkins right 4 100cm infiniti diagnostic catheter broke off in the patient's radial artery during a cardiac cath while visualizing the coronary arteries.This resulted in the patient needing a follow up surgery to remove the tip and was removed successfully.There was no reported patient injury.The product was properly stored and opened in a sterile field.The user was trained to the device.The device was not returned for analysis and the sterile lot number was not provided, as such a product history review could not be performed.The reported ¿brite tip/distal tip-separated¿ could not be confirmed without the return of the device or imaging.With the limited information provided an exact cause for the event could not be determined.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 open or damaged packages.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ the ifu also precautions to use a guidewire when introducing the catheter through the catheter sheath introducer.Forcibly aspirate and flush the catheter with heparinized saline solution at least once very two minutes.Ptef coated guidewires are recommended for use with cordis angiographic catheters.Based on the limited information available 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: CATH F6 INFINITI TL JR 4 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16554408
• Report Number: 9616099-2023-06355
• Device Sequence Number: 16867169
• Product Code: DQO
• UDI-Device Identifier: 10705032014199
• UDI-Public: 10705032014199
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: 534621T
• Device Catalogue Number: 534621T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Sex: Unknown