CORDIS CORPORATION 6MM BASKET, MEDIUM SUPPORT,; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
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Model Number 601814RMC |
Device Problems
Material Frayed (1262); Torn Material (3024)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Complaint conclusion: the angioguard filter basket (6mm basket, medium support) ripped.The malfunction was noticed upon removal from the patient.There was no injury to the patient.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.The intended procedure/target lesion was the left common femoral artery (lcfa).The angioguard was not sized larger than the vessel as instructed in the ifu.The device did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the device towards the lesion.There was no unusual force used at any time during the procedure.Thrombus was not present prior to, at, or after the lesion site.The lesion was not pre-dilated.There was no difficulty or resistance noted while crossing the lesion with the device.The device did not have to pass through a previously placed stent.The filter basket expanded fully with good wall apposition.The lesion was not post-dilated after stent implantation.The product was removed intact (in one piece) from the patient.The product was returned for analysis.A non-sterile 6mm basket, medium support angioguard and capture sheath were returned.Per visual analysis the filter basket was had been deployed.No other damages were noted.Per microscopic analysis the filter basket was returned ripped.A product history record (phr) review of lot 35233440 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter basket - frayed/split/torn - prior to use¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) or the location of the target lesion may have contributed to the rip.The angioguard embolic protection device is indicated for the carotid artery only therefore this is considered off-label usage.According to the indications in the safety information of the instructions for use ¿the angioguard rx emboli capture guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries.The diameter of the artery at the site of filter basket placement should be from 3 mm to 7.5 mm.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
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Event Description
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As reported, the angioguard filter basket (6mm basket, medium support) ripped.The malfunction was noticed upon removal from the patient.There was no injury to the patient.The product will be returned for analysis.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the device prior to use.The intended procedure/target lesion was the lcfa.The angioguard was not sized larger than the vessel as instructed in the ifu.The device did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the device towards the lesion.There was no unusual force used at any time during the procedure.Thrombus was not present prior to, at, or after the lesion site.The lesion was not pre-dilated.There was no difficulty or resistance noted while crossing the lesion with the device.The device did not have to pass through a previously placed stent.The filter basket expanded fully with good wall apposition.The lesion was not post-dilated after stent implantation.The product was removed intact (in one piece) from the patient.
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Search Alerts/Recalls
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