MAUDE Adverse Event Report: CORDIS US. CORP SMART CONTROL ILIAC; STENT, ILIAC

Catalog Number C06100ML

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

As reported, the back luer of the 6x100 smart control was flushed in preparation, it broke off and item was discarded from procedure.No patient harm or usage.Another product (same device) was used to complete case.After the case the account messed with product prior to it being picked up.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the back luer of the 6x100mm smart control was flushed in preparation, it broke off and item was discarded from procedure.No patient harm or usage.Another product (same device) was used to complete case.After the case, the account messed with product prior to it being picked up.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.A non-sterile unit ¿smart control, iliac 6x100ml¿ was received for product evaluation.Per visual analysis, the unit was returned not deployed with the stent mounted.The locking tab was returned not fixed to the device.The luer hub present a fractured/separated condition.The inner lumen was also separated and dissembled from the device.No other outstanding details were observed.Per microscopic analysis, a scanning electron microscope (sem) analysis was not performed because the damages associated with the separations were visible with the magnification obtained with the vision system.The separated condition observed on the luer hub showed striation patterns and plastic deformation.These results led to infer that the separated unit presented evidence of an exposure to an overloading stress force event that occurred to the damaged area of the unit as fatigue striation patterns and plastic deformations are commonly associated with separations in polymeric materials caused by overloading stress force resistance properties.The separated area of the inner lumen was inspected with a vision system, observing that both edges presented evidence of elongations and plastic deformations.The elongations and plastic deformation found on the material are commonly associated with separations caused by material tensile overload.Therefore, it is likely that the device was induced to a tensile force that exceeded the material¿s yield strength prior to the separation.No other anomalies were observed during the evaluation.The reported events of ¿luer hub (outer sheath)-separated¿ and ¿guidewire lumen (inner shaft)-separated¿ were confirmed due to the separated conditions observed to the luer hub and guidewire lumen during visual analysis.However, the exact cause of these damages could not be conclusively determined during the analysis of the returned device.Based on the information available for review and product analysis, prepping/handling factors likely contributed to the separation of the luer hub reported as evidenced by the striation patterns and plastic deformations found during microscopic analysis as these damages suggest the unit was exposed to an overloading stress force.Additionally, the separation of the guidewire lumen that was not reported by the customer was likely due to the manipulations mentioned after the procedure (¿the account messed with product prior to it being picked up¿) as evidenced by the elongations and plastic deformations noted during microscopic analysis.These conditions suggest that the material was induced to a tensile force that exceeded the material¿s yield strength prior to the separation.According to the instructions for use (ifu), which is not intended as a mitigation, preparation of stent delivery system: ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Flush the flushing valve of the stent delivery system with heparinized saline using a 3-cc syringe to expel air.Continue to flush until heparinized saline weeps from the distal catheter end.Flush the guidewire lumen of the stent delivery system with heparinized saline using a 20-cc syringe to expel air.Continue to flush until heparinized saline flows out of the wire lumen at the distal catheter tip.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.¿ neither the product analysis, nor the information available for review suggest that the observed damages are related to the design or manufacturing process of the unit.Additionally, controls are in place to verify the device conditions with 100% inspection.Therefore, no corrective/preventative actions will be taken at this time.

Event Description

As reported, the back luer of the 6x100 smart control was flushed in preparation, it broke off and item was discarded from procedure.No patient harm or usage.Another product (same device) was used to complete case.After the case the account messed with product prior to it being picked up.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.The device will be returned for evaluation.

• Brand Name: SMART CONTROL ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS US. CORP; 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: 18392269
• MDR Text Key: 331342243
• Report Number: 9616099-2023-06673
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C06100ML
• Device Lot Number: 18214955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1