MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 8X60ML; STENT, ILIAC

Model Number	C08060ML
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The smart control iliac 8 x 60mm stent delivery system (sds) distal tip was frayed.The stent was replaced with another (unknown) device and the procedure was completed successfully.There was no patient injury.After an unknown guidewire crossed the lesion, a smart control was advanced to the lesion but it could not advance.Therefore the stent was removed from the patient¿s body and it was found that the distal tip was frayed.The target lesion is unknown.The patient¿s vessel level of tortuosity and calcification is unknown.The rate of stenosis is unknown.The device was prepped according to the instruction for use (ifu) with no difficulties or defects noted.It is unknown what size and brand sheath introducer was used.The target lesion and its characteristics are unknown.It is unknown if there was difficulty tracking the device towards the lesion.It is unknown if the catheter was ever in an acute bend.The product was not returned for analysis.A device history record (dhr) review of lot 17210344 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, although unknown, may have contributed to the reported event as calcification and tortuosity may damage the distal tip of a device when pushed towards the target lesion.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 limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
It was reported that the smart control iliac 8x60ml distal tip was frayed.The stent was replaced with another device (unknown) and the procedure was completed successfully.There was no patient injury.After an unknown guidewire crossed the lesion, a smart control was advanced to the lesion but it could not advance.Therefore the stent was removed from the patient¿s body and it was found that the distal tip was frayed.The target lesion was unknown.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.

• Brand Name: SMART CONTROL, ILIAC 8X60ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6432584
• Report Number: 9616099-2017-00994
• Device Sequence Number: 19028411
• Product Code: NIO
• UDI-Device Identifier: 20705032024133
• UDI-Public: 20705032024133
• 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
• Report Date (Section B): 03/24/2017

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 Expiration Date: 02/28/2017
• Device Model Number: C08060ML
• Device Catalogue Number: C08060ML
• Device Lot Number: 17210344
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1