Model Number 10609 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that a markerband issue was encountered.A 2.50 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the markers (90cm and 100cm) on the shaft were switched.The stent was implanted and the procedure completed.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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The device was not returned for analysis, however a photo was received which showed the shaft of the device and confirmed the 100 cm and 90 cm white hot stamp markers were switched in position.Two markers were located at 90 cm instead of one, and one marker was located at 100 cm instead of two.
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Event Description
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It was reported that a markerband issue was encountered.A 2.50 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the markers (90cm and 100cm) on the shaft were switched.The procedure was completed and there were no patient complications nor injuries reported.
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Manufacturer Narrative
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The synergy ii us otw 2.50 x 12 mm stent delivery system was returned for analysis without the stent.The device was returned without the stent as it was deployed without issues at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted.Balloon folds are partially open, and crimp markings are visible on the exposed balloon wall.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube found no issues.The two hot stamps markers on the hypotube shaft were located at 90 cm proximal to tip instead of one, and one hot stamp marker was located at 100 cm from tip instead of two.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
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Event Description
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It was reported that a markerband issue was encountered.A 2.50 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the markers (90cm and 100cm) on the shaft were switched.The procedure was completed and there were no patient complications nor injuries reported.
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Search Alerts/Recalls
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