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

Model Number PC1040RXC

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

As reported, the precise pro rx could not be deployed after pre-dilation and being delivered to the lesion.It was noted that it was hard to pull the valve.The physician that s/he forgot to open the valve; however, it was noted to be open.The case was completed with new precise (10-30).There was no reported injury to the patient.The device was stored and prepped per the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when it was removed from the tray.There was no difficulty encountered when flushing the stopcock.There was no difficulty while flushing the sds.The intending procedure was a carotid artery stenting (cas).The intended lesion was at the bifurcation.A non-cordis 8f guiding catheter was used.There was no difficulty encountered while advancing the sds towards the lesion.Unusual force was not used during the procedure.No difficulty or resistance was experienced when crossing the lesion.The sds did not pass through any previously places stent.The new stent was deployed without any issues.The device will be returned for analysis.Addendum due to pe findings: added code catheter tip-frayed/split/torn.

Manufacturer Narrative

The precise pro rx could not be deployed after pre-dilation and being delivered to the lesion.It was noted that it was hard to pull the valve.The physician that s/he forgot to open the valve; however, it was noted to be open.The case was completed with new precise (10-30).The device was stored and prepped per the ifu.There was nothing unusual noted about the stent delivery system prior to use.The stent was still constrained within the outer member/sheath when it was removed from the tray.There was no difficulty encountered when flushing the stopcock.There was no difficulty while flushing the sds.The intending procedure was a carotid artery stenting (cas).The intended lesion was at the bifurcation.A non-cordis 8f guiding catheter was used.There was no difficulty encountered while advancing the sds towards the lesion.Unusual force was not used during the procedure.No difficulty or resistance was experienced when crossing the lesion.The sds did not pass through any previously places stent.The new stent was deployed without any issues.There was no reported injury to the patient.The device was returned for analysis.One non-sterile pc1040rxc precise pro rx us carotid syst was received for analysis inside a plastic bag.Per visual analysis, the stent of the unit was received in place, not deployed.The distal tip of the unit was observed over cannulated into the brite tip.The brite tip was observed frayed/ split/ torn damaged.Also, the body shaft of the unit was found separated at the valve and id band area.Besides, the polyamide body shaft was observed kinked damaged, and the valve of the unit was received partially locked.Likewise, the pusher rod was received fully inserted into the body sheath.No other anomalies observed on the unit at a naked eye.Dimensional analysis to measure the stroke length and usable length of the stent delivery system could not be performed due to the separated and damaged condition of the unit the way it was returned for evaluation.Stent deployment functional test was not performed on the unit due to the separated and damaged condition of the unit the way it was returned for evaluation.Per microscopic analysis, the precise pro body shaft separation was observed under the vision system and the separated section of the unit presented elongations and frayed edges.These characteristics are clear evidence on the product in which during analysis of the device, it was noted that an application of tension (force) induced the separation.Also, the kink found on the body shaft of the unit was magnified.No other issues were noted during the microscopic analysis.A product history record (phr) review of lot 18061164 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 ¿ unable¿ was confirmed since the stent of the unit was received in place, not deployed.Nonetheless, the body shaft of the unit was found kinked and separated, as well as the distal tip of the unit was observed over cannulated into the brite tip, causing, in turn, the observed frayed/ split/ torn damaged condition on the brite tip.Therefore, the reported ¿catheter tip-frayed/split/torn" was indeed confirmed.Furthermore, the body shaft separated section of the unit presented elongations and frayed edges, probably caused by an application of a tension force (users¿ interaction with the device during use).The application of tension may have induced the separation of the unit as this was the returned condition noted on the unit for evaluation.However, neither the cause of the separated and damaged condition on the unit, nor the cause of the reported deployment difficulty could be determined during the device evaluation.Procedural and or handling factors such as vessel characteristics and the user¿s interaction with the device during use might have contributed to the damaged conditions on the unit.According to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.¿ additionally, the instructions for use (ifu) states ¿note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the phr review, nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• 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 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14601170
• MDR Text Key: 294137031
• Report Number: 9616099-2022-05685
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: (01)20705032036556(17)230930(10)18061164
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 18061164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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
• Treatment: 8F OPTIMO GUIDE CATH; PRECISE (10-30)