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

Model Number PC0840RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.  device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while removing the precise pro rx us carotid system from the packaging it was found that the system was partially deployed.Another precise pro stent was use to complete the procedure successfully.There were no patient injury.The product was stored and handled according to the instructions for use (ifu). there were no damage noted to the packaging of the devices.The device was stored in the lab for 3 months.There were no difficulty removing the product from the package.The product was discarded and will not be returned for analysis.

Manufacturer Narrative

While removing the precise pro rx us carotid system from the packaging it was found that the system was partially deployed.Another precise pro stent was use to complete the procedure successfully.There were no patient injury.The product was stored and handled according to the instructions for use (ifu).There were no damage noted to the packaging of the devices.The device was stored in the lab for three months.There were no difficulty removing the product from the package.  the product was not returned for analysis.A device history record (dhr) review of lot 17599309 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/prior to use¿ 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 but cannot be confirmed.According to the instructions for use ¿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if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker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 dhr 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.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6449243
• MDR Text Key: 71398346
• Report Number: 9616099-2017-01013
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036488
• UDI-Public: 20705032036488
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: PC0840RXC
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17599309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/07/2017
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1