MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 6X150MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C06150ML
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During use, it was reported that the smart stent failed to cross the lesion after three attempts, the stent was removed and it was noticed that the stent was slightly exposed.There was no reported patient injury.The procedure was completed with balloon dilatations and no dissociation was confirmed.The procedure completed successfully.A contralateral approach was made from the left common femoral artery.An unknown guidewire (014) crossed the lesion and an unknown balloon catheter (3.0*40) was inflated as a pre dilatation.Then a smart stent was inserted but could not cross the lesion.So another pre dilatation was performed with the same balloon catheter and the smart stent attempted to cross the lesion.However it could not cross the lesion.Another unknown balloon catheter (4.0*40) was inflated, but the smart stent could not cross.Therefore it was removed from the patient and it was confirmed that there was a gap between the distal tip and the outer sheath, and the stent was slightly exposed.The target lesion was the right superficial femoral 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
During an interventional procedure to the right superficial femoral artery (sfa), it was reported that a smart stent failed to cross the lesion after three attempts.The stent was removed and it was noticed that the stent was slightly exposed.There was no reported patient injury.The procedure was completed with balloon dilatations and no dissociation was confirmed.The procedure was completed successfully.A contralateral approach was made from the left common femoral artery.An unknown guidewire (.014) crossed the lesion and an unknown balloon catheter (3.0*40) was inflated as a pre- dilatation.Then a smart stent was inserted but could not cross the lesion.A second pre- dilatation was performed with the same balloon catheter and the smart stent attempted to cross the lesion.However it could not cross the lesion.Next, an unknown balloon catheter (4.0*40) was inflated as a pre- dilatation, but the smart stent was still unable to cross.Therefore, it was removed from the patient and it was then confirmed that there was a gap between the distal tip and the outer sheath, and the stent was slightly exposed.The target lesion was the right superficial femoral 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.The product was not returned for analysis.A device history record (dhr) review of lot 17673399 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without procedural films available for review, the clinical cause of the reported stent delivery system- failure to cross could not be confirmed.Vessel characteristic of calcification, as noted by the multiple pre-dilations performed, is a factor in the reported event.The reported ¿stent delivery system- deployment difficulty - premature deployment¿ could not be confirmed as the device was not returned for analysis.The exact causes not be determined.Handling factors may have contributed to the reported event.The product information for safety warns ¿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.Ensure that the tuohy borst valve, connecting the inner shaft and outer sheath, is locked by rotating the proximal valve end in a clockwise direction to prevent premature stent deployment.Advance the device over the guidewire to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Neither the device history record nor the information available suggest that the event could be related to the design or manufacturing process; therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SMART 120 150, SFA - 6X150MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7299336
• Report Number: 9616099-2018-01950
• Device Sequence Number: 957834
• Product Code: FGE
• UDI-Device Identifier: 20705032063408
• UDI-Public: 20705032063408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• 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): 03/19/2018

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: 04/30/2019
• Device Model Number: C06150ML
• Device Catalogue Number: C06150ML
• Device Lot Number: 17673399
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/01/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1