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

Model Number PC0740RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: the precise pro rx (us carotid system) stent was partially deployed within the sterile package.The product was stored and handled in accordance with the ifu (instructions for use).There was no visible damage to the package or the item.There was no further information available.The product was not returned for analysis.A product history record (phr) review of lot 17771397 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Handling factors may have contributed 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.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.

Event Description

As reported, the precise pro rx (us carotid syst) stent was partially deployed within the sterile package.The product was stored and handled in accordance with the ifu.There was no visible damage to the package or the item.There was no further information available.The device will not be returned for analysis.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; 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 ; 7863138372
• MDR Report Key: 8799931
• MDR Text Key: 151622253
• Report Number: 9616099-2019-03084
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036464
• UDI-Public: 20705032036464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: PC0740RXC
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 17771397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2018
• 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