MAUDE Adverse Event Report: CORDIS CORPORATION BRITE TIP; INTRODUCER, CATHETER

Catalog Number	401823M
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	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, an 8f 23 cm brite tip catheter sheath introducer (csi) broke off inside the patient.The physician was figure 8 suturing the access site to remove the sheath when this occurred.Manual removal was attempted with no success.The patient was the converted from monitored anesthesia care to general anesthesia for vascular surgery to make an incision and extract the sheath.The sheath tip was removed successfully from the patient.The device is being returned for evaluation.
Additional Manufacturer Narrative
This report is related to medwatch # (b)(4).Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, an 8f 23 cm brite tip catheter sheath introducer (csi) broke off inside the patient.The physician was figure 8 suturing the access site to remove the sheath when this occurred.Manual removal was attempted with no success.The patient was then converted from monitored anesthesia care to general anesthesia for vascular surgery to make an incision and extract the sheath.The sheath tip was removed successfully from the patient.The device was not returned for evaluation as previously expected.Without the return of the device or images for analysis, the reported customer event ¿catheter sheath introducer (csi)-separated¿ could not be confirmed.Procedural/handling factors such as inserting or 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, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and withdraw the csi.Insertion procedure.Remove the sheath when clinically indicated by placing compression on the vessel above the puncture site, and slowly withdraw the csi.Discard the sheath appropriately.¿ 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.
Event or Problem Description
As reported, an 8f 23 cm brite tip catheter sheath introducer (csi) broke off inside the patient.The physician was figure 8 suturing the access site to remove the sheath when this occurred.Manual removal was attempted with no success.The patient was the converted from monitored anesthesia care to general anesthesia for vascular surgery to make an incision and extract the sheath.The sheath tip was removed successfully from the patient.Additional information was requested but not provided.The device was not returned for evaluation as previously expected.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 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 ; 7863138372
• MDR Report Key: 19201521
• Report Number: 9616099-2024-00131
• Device Sequence Number: 12789037
• Product Code: DYB
• UDI-Device Identifier: 10705032000383
• UDI-Public: (01)10705032000383(17)271231(10)18276426
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/26/2024

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 Catalogue Number: 401823M
• Device Lot Number: 18276426
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 05/10/2024; 08/26/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/14/2024; 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• 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.
• Patient Sex: Unknown