MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Catalog Number PC0840RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a precise pro (rx us carotid syst) self-expanding stent (ses) was deployed partially before putting it into the body.There was no reported patient injury.The device was stored as per labeling.The device was opened in sterile field.The precise ses stent was not used in patient.The device was stored and handled per the instructions for use (ifu).The device was not being used for treatment of a chronic total occlusion.The stent partially deployed when removing.The precise stent pre-maturely deployed.The stent deployed ¼ of it.There was no attempt made to re-capture the stent.The stent was never implanted.There are no pictures available of the cordis devices used.The device will be returned for analysis.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17836347) 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.

Manufacturer Narrative

A precise pro (rx us carotid system) self-expanding stent (ses) was deployed partially before putting it into the body.There was no reported patient injury.The device was stored as per labeling.The device was opened in sterile field.The precise ses stent was not used in patient.The device was stored and handled per the instructions for use (ifu).The device was not being used for treatment of a chronic total occlusion.The stent partially deployed when removing.The precise stent pre-maturely deployed.The stent deployed ¼ of it.There was no attempt made to re-capture the stent.The stent was never implanted.The device was returned for analysis.One non-sterile precise pro rx us carotid stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.Per visual analysis, the valve of the unit was received partially locked/ closed.The stent of the unit was received already deployed and stent was not returned.A kink was observed on the catheter shaft at 8.1 cm from the strain relief.Also, catheter¿s shaft was observed accordioned at 8.5 cm from the strain relief.No other anomalies were observed.Per dimensional analysis the usable length of unit couldn¿t be properly measured due to the kinked and accordioned condition of the unit.Per functional analysis a deployment test couldn¿t be performed since stent was already deployed.A product history record (phr) review of lot 17836347 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¿ was confirmed through analysis of the returned device as the stent had been deployed and was not returned for analysis.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural and handling factors may have contributed to the event as evidenced by a kink and an accordioned condition noted on the shaft during analysis.According to the instructions for use, which is not intended as 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.¿ 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.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8861886
• MDR Text Key: 203007451
• Report Number: 9616099-2019-03118
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

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: 12/31/2020
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17836347
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/08/2019; 09/11/2019
• Supplement Dates FDA Received: 08/30/2019; 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1