Model Number 10607 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/23/2020 |
Event Type
malfunction
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Event Description
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It was reported that stent movement on the balloon occurred.A 4.00 x 38 synergy drug-eluting stent was selected for use; however, the stent started coming off the balloon when the protective sleeve was pulled off.The procedure was completed with another of the same device.
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Event Description
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It was reported that stent moved on balloon occurred.A 4.00 x 38 synergy drug-eluting stent was selected for use; however, the stent started coming off the balloon when the protective sleeve was pulled off.The procedure was completed with another of the same device.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy ii us mr 4.00 x 38mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts were pulled distally from the mid-section of the stent, extending over the distal tip.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were 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 microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.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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Search Alerts/Recalls
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