MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 7MM X 40MM, 135 CM; STENT, CAROTID

Model Number PC0740XCE

Device Problems Detachment Of Device Component (1104); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received. additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported, during the release of a precise stent that the delivery shaft was fractured.The stent was not deployed, it was withdrawn and the procedure was not complete.There were no patient injury.The left carotid artery was 80% stenosis.The precise stent was used with an angioguard.The device was prepped according to the instruction for use (ifu) with no difficulties or defects noted.There was no difficulty advancing the device towards the lesion.There was no excessive force used during the procedure.The device is available for analysis.

Manufacturer Narrative

During the release of a precise stent, it was reported that the delivery shaft was fractured.The stent was not deployed, it was withdrawn and the procedure was not completed.There was no patient injury.The left carotid artery was noted to have 80% stenosis.The precise stent was used with an angioguard.The device was prepped according to the instruction for use (ifu) with no difficulties or defects noted.There was no difficulty advancing the device towards the lesion.There was no excessive force used during the procedure.  the product was returned for analysis.One non-sterile precise pro rx ous carotid system (7mm x 40mm, 135) was received for analysis coiled inside a plastic bag.Per visual analysis, the outer member was received broken\separated at 9 cm from the distal end of the id band.The stent was not deployed and the hemostasis valve was received closed.No other anomalies were found.Sem results showed that the separated sections of the outer member presented elongations and frayed edges.These characteristics presented evidence of a plastic deformation as a result of an application of a pulling tension force.The accordioned condition observed on the proximal separated section indicates that the device was also submitted to a pushing tension force.Hence, the application of both forces might induce the body separation.A device history record (dhr) of lot 17572099 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿stent delivery system (sds)-ses - cracked - in patient¿ was confirmed through analysis of the returned product.The exact cause of the event could not be conclusively determined.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced by evidence of elongations and frayed edges noted on the cracked surface during analysis indicative of excess force being applied to the device.According to the instructions for use, which is not a mitigation of risk ¿extract the stent delivery system from the tray.Examine the device for any damage.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.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ neither the dhr 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.

• Brand Name: PRECISE PRO RX OUS CAROTID SYSTEM, 5F, 7MM X 40MM, 135 CM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6714075
• MDR Text Key: 80062135
• Report Number: 9616099-2017-01244
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: PC0740XCE
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 17572099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/19/2017
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1