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

Model Number	PC0840RXC
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6449243
• Report Number: 9616099-2017-01013
• Device Sequence Number: 567587
• Product Code: NIM
• UDI-Device Identifier: 20705032036488
• UDI-Public: 20705032036488
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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
• Operator of Device: 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
• Distributor Facility Aware Date: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/06/2017
• Patient Sequence Number: 1