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

Model Number C08150ML

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

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

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, the distal tip of an 8mm x 150mm smart ses (self-expanding stent) delivery system was inserted and got frayed when delivered to the lesion.The complaint device was replaced with another smart stent.There was no reported patient injury.The lesion was inflated with balloon catheters.The target lesion was the iliac.Access vessel characteristics included mild calcification and tortuosity in addition to ninety percent stenosis.The temperature exposure indicator on the pouch was not checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when it was removed from the tray.There was no difficulty encountered flushing the stopcock or flushing the sds.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was contralateral.There was no unusual force used at any time during the procedure.The sds did not pass through a previously placed stent.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 18019640 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 for analysis and based on the information provided, the reported ¿catheter tip~ frayed/split/torn - in patient¿ could not be confirmed and the exact root cause could not be determined.Handling/procedural and/or patient factors such as access vessel characteristics including mild calcification and tortuosity in addition to ninety percent stenosis may have contributed to the reported event.According to the instructions for use ¿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 resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent¿.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.

Event Description

As reported, the distal tip of an 8mm x 150mm smart ses (self-expanding stent) delivery system was inserted and got frayed when delivered to the lesion.The complaint device was replaced with another smart stent.There was no reported patient injury.The lesion was inflated with balloon catheters.The target lesion was the iliac.Access vessel characteristics included mild calcification and tortuosity in addition to ninety percent stenosis.The temperature exposure indicator on the pouch was not checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when it was removed from the tray.There was no difficulty encountered flushing the stopcock or flushing the sds.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was contralateral.There was no unusual force used at any time during the procedure.The sds did not pass through a previously placed stent.The device was discarded; therefore, it will not be returned for evaluation.

Manufacturer Narrative

As reported, the distal tip of an 8mm x 150mm smart ses (self-expanding stent) delivery system was inserted and got frayed when delivered to the lesion.The complaint device was replaced with another smart stent.There was no reported patient injury.The lesion was inflated with balloon catheters.The target lesion was the iliac.Access vessel characteristics included mild calcification and tortuosity in addition to ninety percent stenosis.The temperature exposure indicator on the pouch was not checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when it was removed from the tray.There was no difficulty encountered flushing the stopcock or flushing the sds.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was contralateral.There was no unusual force used at any time during the procedure.The sds did not pass through a previously placed stent.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 18019640 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 for analysis and based on the information provided, the reported ¿stent delivery system (sds)-ses~ failure to cross¿ and ¿catheter tip~ frayed/split/torn - in patient¿ could not be confirmed and the exact root cause could not be determined.Handling/procedural and/or patient factors such as access vessel characteristics including mild calcification and tortuosity in addition to ninety percent stenosis may have contributed to the reported event.According to the instructions for use ¿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 resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent¿.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.

Event Description

As reported, the distal tip of an 8mm x 150mm smart ses (self-expanding stent) delivery system was inserted and got frayed when delivered to the lesion.The complaint device was replaced with another smart stent.There was no reported patient injury.The lesion was inflated with balloon catheters.The target lesion was the iliac.Access vessel characteristics included mild calcification and tortuosity in addition to ninety percent stenosis.The temperature exposure indicator on the pouch was not checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when it was removed from the tray.There was no difficulty encountered flushing the stopcock or flushing the sds.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was contralateral.There was no unusual force used at any time during the procedure.The sds did not pass through a previously placed stent.The device was discarded; therefore, it will not be returned for evaluation.

• Brand Name: SMART CONTROL
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 16546672
• MDR Text Key: 311615258
• Report Number: 9616099-2023-06348
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032063415
• UDI-Public: 20705032063415
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: C08150ML
• Device Catalogue Number: C08150ML
• Device Lot Number: 18019640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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
• Treatment: SMART STENT UNK BALLOONS; SMART STENT UNK BALLOONS