MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X30; STENT, CAROTID

Catalog Number PC0830XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17721601 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 Description

As reported, the 8x30 precise pro rx was removed from the packaging and it was noted that the stent had released from the delivery shaft at the distal end and was unable to be used normally.There was no reported patient injury.The device was intended to be used during an interventional procedure.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.A precise pro rx 8mm x 30 mm was removed from the packaging and was noted that the stent had released from the delivery shaft at the distal end and was unable to be used normally.There was no reported patient injury.The device was intended to be used during an interventional procedure.The product was returned for analysis.One non-sterile precise pro rx 8mm x 30mm stent delivery system (sds) was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received partially locked/closed.Per visual analysis, the stent of the unit was deployed, and the stent was returned.Four kinks were observed along the catheter shaft at 8.2 cm, 55.9 m, 57.4 cm and 57.8 cm from the strain relief.Per dimensional analysis, the usable length of unit could not be properly measured due to the kinked and accordion condition of the unit.Deployment test could not be performed since stent was already deployed.The cause of the observed damages could not be conclusively determined during the analysis.A product history record (phr) review of lot 17721601 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) - deployment difficulty - premature/during prep¿ was confirmed since the stent was received deployed.Additionally, the device was observed with several kinks on the catheter body/shaft from procedural usage.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.A.Open the outer box to reveal the pouch containing the stent and delivery system.B.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.C.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.D.While in the tray, attach a stopcock to the y connection on the tuohy borst valve.E.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.F.Close the stopcock attached to the tuohy borst y connection.G.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 event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

The 8x30 precise pro rx was removed from the packaging and it was noted that the stent had released from the delivery shaft at the distal end and was unable to be used normally.There was no reported patient injury.The device was intended to be used during an interventional procedure.Multiple attempts to obtain additional information were unsuccessful.The product was not returned for analysis.A product history record (phr) review of lot 17721601 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 - premature/during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event.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.A.Open the outer box to reveal the pouch containing the stent and delivery system.B.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.C.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.D.While in the tray, attach a stopcock to the y connection on the tuohy borst valve.E.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.F.Close the stopcock attached to the tuohy borst y connection.G.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 nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: PRECISE PRO RX 8X30
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8682396
• MDR Text Key: 147523677
• Report Number: 9616099-2019-03005
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: PC0830XCE
• Device Lot Number: 17721601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1