Model Number 10601 |
Device Problem
Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy ii us mr 3.50 x 28mm stent delivery system was returned for analysis.A visual examination of the stent identified stent damage.Proximal stent strut row 1 was lifted and damaged.The undamaged crimped 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 wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip identified damage.A visual and tactile examination of the hypotube identified multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section identified inner polymer extrusion twisting and damage 55mm proximal from distal end of tip.No other issues were identified during the product analysis.
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Event Description
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Reportable based on device analysis completed on 14nov2019.A 3.50 x 28 synergy drug-eluting stent was opened and was noted to be defective.However, returned device analysis revealed stent damaged.
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Event Description
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Reportable based on device analysis completed on 14nov2019.A 3.50 x 28 synergy drug-eluting stent was opened and was noted to be defective.However, returned device analysis revealed stent damaged.
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Manufacturer Narrative
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Device is a combination product.Date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy ii us mr 3.50 x 12mm stent delivery system was returned for analysis.A visual examination of the stent identified stent damage.Proximal stent strut row 1 was lifted and damaged.The undamaged crimped stent outer diameter was measured within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip identified damage.A visual and tactile examination of the hypotube identified multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section identified inner polymer extrusion twisting and damage 55mm proximal from distal end of tip.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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