Model Number 10623 |
Device Problems
Break (1069); Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.During insertion of a 3.5 x 38mm synergy ii drug-eluding stent resistance was encountered.The device was removed and a shaft break was noted.The procedure was successfully completed with a different device.
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Manufacturer Narrative
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Device is a combination product.A 3.50 x 38mm synergy stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found no issues with 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 between the proximal and distal marker bands.The crimped stent od (outer diameter) was measured by snap gauge and the result was within max crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube identified a fracture in the lasercut region at 109.5 cm distal to the distal end of strain relief.A hypotube kink was also identified 23.5 cm distal to the distal end of strain relief.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) found no issues with the tip.No other issues were identified during the product analysis.
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Event Description
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It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed.During insertion of a 3.5 x 38mm synergy ii drug-eluding stent resistance was encountered.The device was removed and a shaft break was noted.The procedure was successfully completed with a different device.
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Search Alerts/Recalls
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