MAUDE Adverse Event Report: CORDIS CORPORATION SMART FLEX 6X150 BIL, 120CM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	SF06150MB
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported, the stent of a 6x150 120cm biliary smart flex self-expanding stent (ses) delivery system opened up but could not be deployed and got dislodged.About 1/3 of the stent was able to be deployed inside the patient.After not being able to deploy the stent any further, the physician indicated he was able to pull the entire stent and catheter assembly into the 6fr non-cordis sheath he had parked in the superficial femoral artery (sfa).Then, the entire sheath was removed with the stent inside completely out of the patient¿s body.The procedure was completed with another smart flex.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The temp indicator did not show any unusual details and was visible.There were absolutely no signs of faulty on the device.When removed from the tray, the stent was intact and covered with an outer sheath.The device was prepped according to the ifu.The lesion was not calcified nor tortuous.There was no resistance/friction during insertion of the device.The device was able to cross the lesion.The stent failed inside the vessel at the target area when it was deployed.The stent was still attached to the delivery system upon removal of the device and was removed in one piece.The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: complaint conclusion: the stent of a 6x150mm 120cm biliary smart flex self-expanding stent (ses) delivery system opened up but could not be deployed and got dislodged.About 1/3 of the stent was able to be deployed inside the patient.After not being able to deploy the stent any further, the physician indicated he was able to pull the entire stent and catheter assembly into the 6fr non-cordis sheath he had parked in the superficial femoral artery (sfa).Then, the entire sheath was removed with the stent inside completely out of the patient¿s body.The procedure was completed with another smart flex.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The temp indicator did not show any unusual details and was visible.There were absolutely no signs of faulty on the device.When removed from the tray, the stent was intact and covered with an outer sheath.The device was prepped according to the ifu.The lesion was not calcified nor tortuous.There was no resistance/friction during insertion of the device.The device was able to cross the lesion.The stent failed inside the vessel at the target area when it was deployed.The stent was still attached to the delivery system upon removal of the device and was removed in one piece.The product was not returned for analysis.A product history record (phr) review of lot 308348 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event.Vessel characteristics (although unknown) may have contributed to the reported event.According to the safety information in the instructions for use ¿the s.M.A.R.T.Flex biliary stent system is indicated for use in the palliation of malignant strictures in the biliary tree.The safety and effectiveness of this device for use in the vascular system have not been established.If resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Warning: do not forcefully remove delivery system from introducer/sheath ¿ if resistance is met, remove sheath and delivery system as a unit.¿ the usage described in this event is considered off label.Neither the phr review nor the information provided suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SMART FLEX 6X150 BIL, 120CM
• Common Device Name: CATHETER, BILIARY, 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: 16128178
• Report Number: 3005089785-2023-00014
• Device Sequence Number: 12671646
• Product Code: FGE
• UDI-Device Identifier: 20705032066034
• UDI-Public: (01)20705032066034(17)241101(10)308348
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130981
• 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): 01/26/2023

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: 11/01/2024
• Device Model Number: SF06150MB
• Device Catalogue Number: SF06150MB
• Device Lot Number: 308348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/26/2023
• Date Device Manufactured: 11/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F TERUMO DESTINATION SHEATH; ANOTHER SMART FLEX
• Patient Age: 57 YR
• Patient Sex: Male