MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 7F 11CM STR; INTRODUCER, CATHETER

Model Number	401711M
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	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the rotating hemostatic valve of a 7f 11cm brite tip catheter sheath introducer (csi) was "released easily" when the sheath was inserted.The device was replaced with another brite tip sheath.The procedure and vascular closure with the hemostasis plug was completed successfully.There was no reported patient injury.The sheath was used with a cordis exoseal device for closure after an endovascular therapy (evt) case.The device will not be returned for evaluation as it was discarded by the site.
Additional Manufacturer Narrative
The product history review is expected but has not been completed.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, h1, h2, h6, and h10.Complaint conclusion: as reported, the rotating hemostatic valve of a 7f 11cm brite tip catheter sheath introducer (csi) was "released easily" when the sheath was inserted.The device was replaced with another brite tip sheath.The procedure and vascular closure with the hemostasis plug was completed successfully.There was no reported patient injury.The sheath was used with a cordis exoseal device for closure after an endovascular therapy (evt) case.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 18038007 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿hemostasis valve/hub- separated - during use¿ could not be confirmed.Procedural or handling factors may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.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.¿ the ifu also instructs users to ¿insert the vessel dilator through the csi¿s hemostasis valve, snapping it into place at the hub.Flush with heparinized saline or suitable isotonic solution.¿ if a leakage or a separated condition is noted at this time, users are trained to identify this condition and immediately switch out the device for a new one.Neither the phr, nor the product analysis available, suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SI BRITE TIP 7F 11CM STR
• Common Device Name: INTRODUCER, CATHETER
• 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: 13167515
• Report Number: 9616099-2022-05253
• Device Sequence Number: 14472813
• Product Code: DYB
• UDI-Device Identifier: 20705032000304
• UDI-Public: 20705032000304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 01/21/2022

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: 06/30/2024
• Device Model Number: 401711M
• Device Catalogue Number: 401711M
• Device Lot Number: 18038007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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: EXOSEAL; SI BRITE TIP 7F 11CM STR- CATALOG #401711M
• Patient Sex: Unknown