MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 8X150MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C08150ML
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17884441 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
After a wire crossed the lesion, the 8mm x 150mm smart control self expanding stent (ses) was inserted however, it was difficult to deliver to the lesion.Therefore, it was removed from the patient¿s body and the physician found out that the distal end of the tip was frayed.The device was replaced with a new smart stent and the procedure was completed.There was no reported patient injury.The lesion was the iliac artery.The device will not be returned for evaluation as it discarded due to infectious disease.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2 and h6 have been updated accordingly.After a wire crossed the lesion, a smart control 8 mm x 150 mm self expanding stent (ses) was inserted however, it was difficult to deliver to the lesion.Therefore, it was removed from the patient¿s body and the physician found out that the distal end of the tip was frayed.The device was replaced with a new smart stent and the procedure was completed.The lesion was the iliac artery.There was no reported patient injury.Additional procedural details were requested but are unknown.The device was not returned for analysis.A product history record (phr) review of lot 17884441 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the limited information provided, the reported ¿catheter tip- frayed/split/torn - in patient¿ could not be confirmed and the exact root cause could not be determined.Handling and or procedural factors such as vessel characteristics (although unknown) may have contributed to the reported event.According to the instructions for use, which are 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.Advance the device over the guide wire 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 phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART 120 150, SFA - 8X150MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9913592
• Report Number: 9616099-2020-03616
• Device Sequence Number: 3272679
• Product Code: FGE
• UDI-Device Identifier: 20705032063415
• UDI-Public: 20705032063415
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 07/31/2021
• Device Model Number: C08150ML
• Device Catalogue Number: C08150ML
• Device Lot Number: 17884441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK WIRE