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As reported, the distal end of a precise pro rx (us carotid system) was confirmed to be kinked when it tried to be delivered.It was removed from the patient and it seemed that the distal end was cracked.Therefore, it was replaced with another precise pro rx of the same size and the procedure was completed.There was no reported patient injury.The product was clinically used and will be returned for analysis.
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As reported, the distal end of a precise pro rx (us carotid system) was confirmed to be kinked when it tried to be delivered.It was removed from the patient and it seemed that the distal end was cracked.Therefore, it was replaced with another precise pro rx of the same size and the procedure was completed.There was no reported patient injury.The product was clinically used and will be returned for analysis.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in the open position when received.The tuohy borst valve was not closed prior to removing the device from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no difficulty encountered flushing the stent delivery system (sds).The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.An 8f sheath introducer was used.The sheath introducer was a non-cordis device.The access site was the right-femoral artery.The access site vessel was reported to be slightly calcified with no scarring.The target site vessel was reported to be severely calcified and tortuous with 75% stenosis.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The other devices used with the product did not kink or bend at any time.
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During a carotid artery stenting procedure, the distal end of a precise pro rx (us carotid system) was confirmed to be kinked during attempted delivery.When the device was removed from the patient it was also noted that the distal end was cracked.Therefore, it was replaced with another precise pro rx of the same size and the procedure was completed.There was no reported patient injury.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in the open position when received.The tuohy borst valve was not closed prior to removing the device from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered when flushing the stopcock.There was no difficulty encountered when flushing the stent delivery system (sds).The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.An 8f non-cordis sheath introducer was used.The access site was the right-femoral artery, which was reported to be slightly calcified with no scarring.The target site vessel was reported to be severely calcified and tortuous and 75% stenotic.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The other devices used with the product did not kink or bend at any time.No other information was reported.The device was returned for analysis.A non-sterile precise pro rx us carotid syst was received coiled inside in plastic bag.Per visual analysis, a frayed/ripped/split and a cracked condition were noted on the brite tip.The unit was received partially deployed (.5 cm), the hemostasis valve was received open.The original packaging was not received.No other damages/anomalies were noted on the unit.The outer sheath diameter (od) was measured and results were found within specification.Usable length was measured, and the results were found within specification.A product history record (phr) review of lot 17685452 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.The phr review does not suggest that the events reported by the customer could be related to the manufacturing process.The events reported as ¿catheter tip- frayed/split/torn¿, ¿stent delivery system (sds)-ses- deployment difficulty - partial deployment¿ and "catheter tip- cracked - in patient¿ were confirmed due to the condition of the received device.The exact cause of the events reported could not be conclusively determined.As per the instructions for use (ifu), which is not intended as a mitigation, ¿the cordis precise pro rx nitinol stent system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.The system should be prepped in the sterile tray per the instructions below.Close the tuohy borst valve prior to removing the device from the tray.Open the outer box to reveal the pouch containing the stent and delivery system.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a gray background is clearly visible.Do not use if entire temperature exposure indicator is completely black as the unconstrained stent diameter may have been compromised.After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel the pouch open and remove the tray.Without removing the device from the tray, examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.With the device in the tray, attach a stopcock to the y connection on the tuohy borst valve.With the device still in the tray, attach a 5-cc syringe filled with heparinized saline to the opened stopcock and apply positive pressure until heparinized saline weeps from the proximal end of the tuohy borst valve.Lock the tuohy borst valve.Close the stopcock attached to the tuohy borst y connection.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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.During delivery, 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 evaluation suggests that the damages found on the device are related to the manufacturing process.Nonetheless, vessel characteristics such as a high degree of stenosis and tortuosity, as well as procedural and handling factors may have contributed to these damages.Therefore, no corrective or preventive actions will be taken at this time.
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Additional information was received and identified the device reported under case case-2018-00028059-1 (manufacturer report number: 9616099-2018-02074) corresponds to the reported events under this case (case-2018-00029804).The product analysis is as follows: per visual analysis, a frayed/ripped/split condition was noted on the brite tip.The unit was received partially deployed, the hemostasis valve was received open.No other damages/anomalies were observed on the unit.The outer sheath diameter (od) was measured at different distances and results were found within specification.During the analysis it was concluded that unusual forces/tension had been applied on the device.Additional information is pending and will be submitted within 30 days upon receipt.
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