MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 10X80 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number C10080SV

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: a smart control 10mm x 80mm 80cm self-expanding stent (ses) was not deployed using the handle.Therefore, it was removed from the patients body.It was unknown if any stent(s) were implanted instead of the smart device.The target lesion was the iliac artery.There was no reported patient injury.The device was returned for analysis.A non-sterile ses smart control 10x80 80 was received coiled inside a plastic bag.Pin lock was not received.Per visual analysis, the body/shaft was observed torn approximately at 15 cm from the strain relief.Also, the outer member was observed separated near the stent.Stent was not deployed from the unit.Handle was observed covered with blood residues.No other anomalies were observed on the unit.Per functional analysis, deployment test could not be performed on the device since the body/shaft of the catheter was received torn and the outer member was observed separated.Per microscopic analysis, results showed that the torn area of the body/shaft of the ses smart control 10x80 80 unit presented evidence of elongations on body/shaft material.Plastic deformation and ductile dimples were found on the separated braid wire surfaces.Results also showed that the separated area of the body/shaft presented evidence of elongations on body/shaft material.Plastic deformation resulting in diameter reduction and tension marks were observed on braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the body/shaft material, the ductile dimples and plastic deformations resulting in a diameter reduction and tension marks, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft material was induced to a tensile force that exceeded the braid wire and body/shaft material yield strength prior to the separation.No other anomalies were observed.The reported stent delivery system (sds)-ses - deployment difficulty - unable was not confirmed since deployment test could not be performed due to the torn and separated condition observed on the unit.The reported "guidewire lumen (inner shaft)-frayed/split/torn" was confirmed since the guidewire lumen and the body/shaft of the device was observed torn, as received.However, microscopic analysis results showed that the torn area of the body/shaft and the separated area of the outer member presented evidence of elongations.Plastic deformation resulting in diameter reduction and tension marks were observed on braid wires.Also, ductile dimples were found on the separated braid wire surfaces.These damages are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the body/shaft and the outer member material were induced to a tensile force that exceeded the catheter material strength prior to the material separation.Nonetheless, the cause of the torn and separated condition on the unit could not be conclusively determined during the analysis.Handling and or procedural factors such as vessel characteristics (although unknown) and user using tensile forces may have led to the reported events.According to the instructions for use, which are not intended as a mitigation of risk, "safety and effectiveness has not been demonstrated in: lesions that are either totally or densely calcified.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If it is suspected that the sterility has been compromised or the device is damaged do not use the device.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, a 10mm x 80mm 80cm smart control self-expanding stent (ses) was not deployed using the handle.Therefore, it was removed from the patients body.There was no reported patient injury.The device was received for evaluation and the guidewire lumen and the body/shaft of the catheter was received torn.It was unknown if any stent(s) were implanted instead of the smart device.The target lesion was the iliac artery.

• Brand Name: SES SMART CONTROL 10X80 80
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10184683
• MDR Text Key: 196967660
• Report Number: 9616099-2020-03761
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: C10080SV
• Device Catalogue Number: C10080SV
• Device Lot Number: 17890229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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