MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE PRO RX 7X30; STENT, CAROTID

Catalog Number PC0730XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis; however, it has not yet been received.A 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, when removing the stent from the protective packaging it was noted that was partially released and the product was available to use.A same like product was used to complete the procedure.The product was stored according to labelling.The product will be returned for analysis.The intended procedure was a carotid angioplasty.

Manufacturer Narrative

The intended procedure was a carotid angioplasty of the ostium of the internal carotid artery.There were no damages or anomalies noted to the device prior to removal from the packaging, and there were no damages noted to the packaging prior to opening.There was no difficulty experienced as the device was removed from the packaging; and the product was stored, inspected and handled according to the instructions for use (ifu).The tuohy borst valve was in the opened position (as always) when received, and it was closed by the surgeon.Complaint conclusion: when removing the stent from the protective packaging it was noted that it was partially released and the product was available to use.A same like product was used to complete the procedure.The product was stored according to labeling.The intended procedure was a carotid angioplasty of the ostium of the internal carotid artery.There were no damages or anomalies noted to the device prior to removal from the packaging, and there were no damages noted to the packaging prior to opening.There was no difficulty experienced as the device was removed from the packaging; and the product was stored, inspected and handled according to the instructions for use (ifu).The tuohy borst valve was in the opened position (as always) when received, and it was closed by the surgeon.The product was not returned for analysis.A device history record (dhr) review of lot 17237571 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 deployment¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Handling factor, although unknown, may have contributed to the reported event.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.¿ neither the dhr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: PRECISE PRO RX 7X30
• 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 ave; miami lakes, FL 33014
• MDR Report Key: 6028163
• MDR Text Key: 57399999
• Report Number: 9616099-2016-00657
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: PC0730XCE
• Device Lot Number: 17237571
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/22/2016
• Date Manufacturer Received: 10/17/2016
• Date Device Manufactured: 05/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1