MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; STENT, CAROTID

Model Number PC0940XCE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17935175 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 head-tip of the 9mm x 40mm precise pro rapid exchange (rx) carotid stent ¿fell into during the operation.¿ there was no reported patient injury.The device is expected to be returned for analysis.An image is available for review.

Manufacturer Narrative

The head-tip of the 9mm x 40mm precise pro rapid exchange (rx) carotid stent ¿fell into during the operation.¿ there was no reported patient injury.The product was not received for analysis, instead one picture related to the reported event was received.In the image, the outer label can be observed, and the following information can be read: lot#17935175, catalog# pc0940xce, use by date # 2022-02-28.No other anomalies of the product can be noticed on the attached picture.A review of the manufacturing documentation associated with lot 17935175 presented no issues during the manufacturing process that can be related to the reported event.The reported ¿catheter tip- separated¿ could not be confirmed as part of the picture analysis.The root cause of the reported event by the customer could not be conclusively determined during the analysis of the picture analysis.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device and vessel characteristics (although unknown) may have led to the reported event.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if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker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 phr review nor the information available suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11147592
• MDR Text Key: 227730513
• Report Number: 9616099-2021-04186
• 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
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17935175
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1