MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 10X40; STENT, ILIAC

Model Number C10040SL

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

During preparation for an endovascular interventional procedure (evt), after opening the pouch for the smart control iliac 10 x 40 stent delivery system (sds) the distal tip was noted to be frayed.Another same size smart control was used to complete the procedure successfully.There was no reported patient injury.An eight (8) cm.Smart stent had been placed prior to the reported product issue.The target lesion was the external iliac artery.No target lesion characteristic information was provided.Additional information received indicated that the product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.No additional target lesion/target lesion characteristic information is available.There was no reported product issue with the 8 cm.Smart stent that was placed prior to the reported product issue.No additional information is available.The product was not returned for analysis.A device history record (dhr) review of lot 17572787 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip frayed/split/torn - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is unknown what factors may have contributed to this issue between manufacture and the customer noting the reported event.Handling factors may have contributed to the reported event as no damage to the packaging was noted.According to the instructions for use, which is not intended as a mitigation, ¿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.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.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Please note that this is the initial/final report for this product.

Event Description

As reported, during preparation for an endovascular interventional procedure (evt), after opening the pouch for the smart control iliac 10 x 40 stent delivery system (sds) the distal tip was noted to be frayed.Another same size smart control was used to complete the procedure successfully.There was no reported patient injury.The product was not clinically used and it will not be returned for analysis.An eight (8) cm.Smart stent had been placed prior to the reported product issue.The target lesion was the external iliac artery.No target lesion characteristic information was provided.Additional information received indicated that the product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.No additional target lesion/target lesion characteristic information is available.There was no reported product issue with the 8 cm.Smart stent that was placed prior to the reported product issue.No additional information is available.

• Brand Name: SMART CONTROL, ILIAC 10X40
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6611510
• MDR Text Key: 76745861
• Report Number: 9616099-2017-01144
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: C10040SL
• Device Catalogue Number: C10040SL
• Device Lot Number: 17572787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/17/2017
• Date Manufacturer Received: 05/17/2017
• Date Device Manufactured: 09/27/2016
• 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