MAUDE Adverse Event Report: CORDIS US CORP. BRITE TIP; INTRODUCER, CATHETER

Catalog Number	401655M
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	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 6f 55cm brite tip sheath introducer did not slide at the end of the intervention when removing the introducer.The physician managed to make it slide with delicate and slow movements.The sheath began to stretch and finally became broken, leaving the distal part in the patient.Fortunately, using christophe forceps, the physician was able to catch and managed to recover the missing part of the introducer.The device was used in a cross over ¿ael¿ procedure.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, the 6f 55cm brite tip sheath introducer did not slide at the end of the intervention when removing the introducer.The physician managed to make it slide with delicate and slow movements.The sheath began to stretch and finally became broken, leaving the distal part in the patient.Fortunately, using christophe forceps, the physician was able to catch and managed to recover the missing part of the introducer.The device was used in a cross over ¿ael¿ procedure.Without the return of the device or images for analysis, the reported customer event ¿catheter sheath introducer-separated¿ could not be confirmed.Handling factors such as withdrawing the device against resistance 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, ¿remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.¿ based on the information available, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17978249
• Report Number: 9616099-2023-06615
• Device Sequence Number: 2453590
• Product Code: DYB
• UDI-Device Identifier: 10705032000277
• UDI-Public: 10705032000277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 401655M
• Device Lot Number: 18221460
• Was Device Available for Evaluation?: No
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2023
• 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
• Patient Sex: Unknown