MAUDE Adverse Event Report: CORDIS CASHEL SMART CONTROL; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	C07150ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the package of the 7x150mm smart 120 stent was opened, and stent was noted to be partially deployed.The patient was fine with no injury.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
Event or Problem Description
As reported, the package of the 7x150mm smart 120 stent was opened, and stent was noted to be partially deployed.The patient was fine with no injury.Additional information and device return was requested; however, both were not obtained after multiple attempts made.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, h1, h2, h3 and h6 the package of the 7x150mm smart 120 stent was opened, and stent was noted to be partially deployed.Additional information and device return was requested; however, both were not obtained after multiple attempts made.The patient was fine with no injury.The product was not returned for analysis.A product history record (phr) review of lot 18103855 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses~ deployment difficulty - premature/during prep¿ was not confirmed.The device was not returned for analysis, and neither were procedural film/images.Procedural factors such as the user¿s interaction with the device during device preparation may have likely contributed to the reported event.However, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the events reported.According to the instructions for use (ifu) ¿ensure that the tuohy borst valve, connecting the inner shaft and outer sheath, is locked by rotating the proximal valve end in a clockwise direction to prevent premature stent deployment.Advance the device over the guidewire to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16816814
• Report Number: 9616099-2023-06478
• Device Sequence Number: 19283749
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: (01)20705032063439(17)240331(10)18103855
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042969
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• Device Expiration Date: 03/31/2024
• Device Model Number: C07150ML
• Device Catalogue Number: C07150ML
• Device Lot Number: 18103855
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2022
• 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
• Patient Sex: Unknown