Lot Number 0031008858 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3 date of event: used the first date of the month of the aware date as no event date was provided.
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Event Description
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It was reported that shaft break occurred.A 3.50 x 32mm synergy xd drug-eluting stent (des), 3.50 x 38mm synergy xd des, and a 3.50 x 48mm synergy xd des were advanced for treatment.However, during the procedure, the shaft of the three devices were broken.The procedure was completed with an alternative device and there were no patient complications reported.
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Manufacturer Narrative
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B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by manufacturer: synergy xd mr us 3.50 x 32mm stent delivery system was returned for analysis.A visual, tactile, microscopic and dimensional analysis were performed on the device.A visual and tactile inspection revealed multiple hypotube kinks and a break at 29cm distal to the distal end of the strain relief were noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A visual, tactile, and microscopic analysis revealed stent struts were lifted at the distal section of the stent.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The undamaged crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.No other device issues were identified during returned product analysis.
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Event Description
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It was reported that shaft break occurred.A 3.50 x 32mm synergy xd drug-eluting stent (des), 3.50 x 38mm synergy xd des, and a 3.50 x 48mm synergy xd des were advanced for treatment.However, during the procedure, the shaft of the three devices were broken.The procedure was completed with an alternative device and there were no patient complications reported.
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Search Alerts/Recalls
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