MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 7X150MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C07150ML
Medical Device Problem Codes	Bent (1059); Difficult or Delayed Positioning (1157); Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A smart stent 7x150mm was prepared and flushed.However the shaft got kinked easily.The device was replaced with a new smart stent (7x120mm) and the procedure was completed successfully.There was no patient injury.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness and calcification is unknown.The rate of stenosis is unknown.The device was prepped according to the instructions for use (ifu).There was no excessive force used during prep.There were no damages noted to the device packaging.There was no difficulty removing the device from the packaging.No other information was provided.The product was returned for analysis.Two non-sterile smart units were returned.The non-sterile complaint product smart 120 150, sfa - 7x150mm stent delivery system (sds) was returned.An additional smart 120 150, sfa - 7x120mm sds was also returned.Per visual analysis premature deployment was noted on the smart 7x150 mm sds.No other anomalies were noted.A product history record (phr) review of lot 17620085 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses kinked/bent,¿ was not confirmed by analysis of the returned device as no kinked/bent condition was found on the device.The exact cause of the reported event could not be determined.According to the instructions for use, although this is not intended as a mitigation of risk, ¿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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
During prep, a smart stent 7x150mm was prepared and flushed.However the shaft got kinked easily.Additional information was received and during fal analysis, it was noted that the stent was premature deployed.The device was replaced with a new smart stent (7x120mm) and the procedure was completed successfully.There was no patient injury.The target lesion was the superficial femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device was prepped according to the instruction for use (ifu) there was excess force used during prep.There was no damages noted to the device packaging.There was no difficulty removing the device from the packaging.The product was not clinically used and will be returned for analysis.No other information was provided.

• Brand Name: SMART 120 150, SFA - 7X150MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7317036
• Report Number: 9616099-2018-01964
• Device Sequence Number: 11291845
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: 20705032063439
• 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
• Report Date (Section B): 03/06/2018

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: 10/31/2018
• Device Model Number: C07150ML
• Device Catalogue Number: C07150ML
• Device Lot Number: 17620085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Distributor Facility Aware Date: 02/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1