MAUDE Adverse Event Report: CORDIS CASHEL PRECISE PRO RX 8X40; STENT, CAROTID

Model Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

A significant kink on the delivery shaft near the stent was found when the package of 8x40 precise pro rapid exchange (rx) was opened.The device could not be used; therefore, it was replaced with a new stent to complete the operation.Medical history included left carotid artery stenosis.The device was stored, prepped and handled per the instructions for use (ifu).There was difficulty experienced in prepping the device.There were no anomalies noted to the packaging of the device.The lesion was calcified.There was severe vessel tortuosity.The percentage of stenosis was at 70%.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no reported patient injury.The product was returned for analysis.One non-sterile precise pro rx 8x40 stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received partially locked.Per visual analysis, a kink was observed on the body/shaft of the catheter approximately at 27.8 cm from the strain relief.Also, stent was observed deployed approximately 8 mm from the unit.No other anomalies were observed.Per dimensional analysis, usable length and outer sheath length of the unit couldn¿t be properly measured due to the kinked condition of the unit, as received.Per functional analysis deployment test was performed successfully on the unit; neither resistance nor any anomalies were observed during the test.No damages were observed on the stent.A product history record (phr) review of lot 17881366 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 - deployment difficulty - partial deployment¿ was confirmed since the stent was observed partially deployed from the unit, as received.The complaint reported by the customer as ¿stent delivery system (sds)-ses - kinked/bent - during prep¿ was confirmed since a kink was observed on body/shaft of the catheter.However, the cause of the kink or the partially deployed unit¿s condition as received could not be conclusively determined.Procedural and or handling factors such as user technique may have led to the reported events.According to the instructions for use, which are not intended as a mitigation of risk, ¿preparation of stent delivery system caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.Open the outer box to reveal the pouch containing the stent and delivery system.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a grey background is clearly visible.See warnings section.After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and remove the tray.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.While in the tray, attach a stopcock to the y connection on the tuohy borst valve.Attach a 5-cc syringe filled with heparinized saline to the open stopcock and apply positive pressure until saline weeps from the proximal end of the tuohy borst valve.Lock the tuohy borst valve.Close the stopcock attached to the tuohy borst y connection.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.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 reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, a significant kinked of the delivery shaft near the stent was found when the package of 8x40 precise pro rapid exchange (rx) was opened.Additional information was received from fal and the stent was observed deployed approximately 8 mm from the unit.The device could not be used; therefore, it was replaced with a new stent to complete the operation.There was no reported patient injury.Medical history included left carotid artery stenosis.The device was stored, prepped and handled per the instructions for use (ifu).There was difficulty experienced in prepping the device.There were no anomalies noted to the packaging of the device.The lesion was calcified.There was severe vessel tortuosity.The percentage of stenosis was at 70%.The device was not used for a chronic total occlusion (total occlusion >3 months).The device will be returned for analysis.

• Brand Name: PRECISE PRO RX 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10086630
• MDR Text Key: 198297359
• Report Number: 9616099-2020-03714
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17881366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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
• Patient Weight: 65