MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 8X40; STENT, ILIAC

Model Number	C08040SL
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the smart control stent distal tip was frayed.Therefore, the stent was replaced with another one and the procedure was completed successfully.There was no reported patient injury.A contralateral approach was attempted with the smart control stent but its tip got stuck and found that the tip was frayed.The target lesion was the iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The product was clinically used and will not be returned for analysis.
Additional Manufacturer Narrative
It was reported that the smart control stent distal tip was frayed.Therefore, the stent was replaced with another one and the procedure was completed successfully.There was no reported patient injury.A contralateral approach was attempted with the smart control stent but its tip got stuck and found that the tip was frayed.The target lesion was the iliac artery.The patient¿s vessel level of tortuousness and calcification are unknown.The rate of stenosis is unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17582238 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 - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors are unknown but may have contributed to the reported event as it was reported the tip got stuck.According to the instructions for use ¿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.

• Brand Name: SMART CONTROL, ILIAC 8X40
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6301300
• Report Number: 9616099-2017-00892
• Device Sequence Number: 1105919
• Product Code: NIO
• UDI-Device Identifier: 20705032024119
• UDI-Public: 20705032024119
• Combination Product (Y/N): N
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2017

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 Model Number: C08040SL
• Device Catalogue Number: C08040SL
• Device Lot Number: 17582238
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1