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

Model Number PC0740RXC

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tip of the precise stent was deformed; additional information was received and the tip of the precise stent is cracked.It is unknown how the procedure was completed but the procedure was completed successfully.There was no patient injury.A precise pro was prepared and used.However, the distal tip was deformed and an unknown guidewire could not be inserted.The target lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The device was prepped according to the instruction for use (ifu).There was no excess force used during prep.There were no damages noted to the device packaging.There were no difficulty removing the device from the packaging.The device was stored according to the ifu.The product was clinically used, discarded, and will not be returned for analysis.No other information was provided.The product was not returned for analysis.A device history record (dhr) review of lot 17487337 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported delivery catheter tip cracked prior to use and catheter tip kinked/bent prior to use could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.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if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker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.

Event Description

It was reported that the tip of the precise stent was deformed; additional information was received and the tip of the precise stent is cracked.It is unknown how the procedure was completed but the procedure was completed successfully.There was no patient injury.A precise pro was prepared and used.However, the distal tip was deformed and an unknown guidewire could not be inserted.The target lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The device was prepped according to the instruction for use (ifu).There was no excess force used during prep.There were no damages noted to the device packaging.There were no difficulty removing the device from the packaging.The device was stored according to the ifu.The product was clinically used, discarded, and will not be returned for analysis.No other information was provided.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th 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
• MDR Report Key: 7076754
• MDR Text Key: 94218141
• Report Number: 9616099-2017-01646
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036464
• UDI-Public: 20705032036464
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: PC0740RXC
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 17487337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/05/2017
• Date Manufacturer Received: 11/05/2017
• Date Device Manufactured: 05/11/2016
• 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