Model Number H7493926220300 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.(b)(4).
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Event Description
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It was reported that shaft break occurred.The 83% stenosed target lesion located in the mid-left circumflex (mlcx) artery.A 3.00 x 20 synergy¿ drug eluting stent (des) was advanced but failed to cross the lesion.The device was removed and it was noted that the shaft kinked.During the course of the procedure, the shaft broke.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and is within the maximum crimped stent profile measurement.The bumper tip of the device showed no signs of damage.The balloon body was reviewed and no issues were noted with the overall balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found that the hypotube was broken 232 mm distal from the strain relief with multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was further reported that the broken part of shaft was positioned outside the patient.The device was completely removed from the patient.
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Search Alerts/Recalls
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