Model Number 10619 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/29/2020 |
Event Type
malfunction
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Event Description
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It was reported that shaft break occurred.A 2.25 x 20mm synergy drug-eluting stent was advanced for treatment.However, it was noted during withdrawal that the shaft extension broke.The device was removed and the procedure was completed.There were no patient complications reported and the patient was stable.
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Manufacturer Narrative
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Device evaluated by mfr: synergy ous mr 2.25 x 20mm stent delivery system (sds) was returned for analysis.The device was returned without the stent attached.The balloon cones were reviewed, and they were in a deflated state.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found a break located at 1mm distal to the distal end of the strain relief as well as multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
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Event Description
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It was reported that shaft break occurred.A 2.25 x 20mm synergy drug-eluting stent was advanced for treatment.However, it was noted during withdrawal that the shaft extension broke.The device was removed and the procedure was completed.There were no patient complications reported and the patient was stable.
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Search Alerts/Recalls
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