Model Number 10607 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device is a combination product.
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Event Description
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It was reported that shaft break occurred.A 3.00 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the shaft broke.The device was pulled out from the patient's body and the procedure was completed with another of the same device.There were no patient complications reported and the patient was fine.
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Manufacturer Narrative
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Device is a combination product.Device evaluated by mfr.: synergy ii us mr 3.00 x 38 mm stent delivery system was returned for analysis attached to a guidewire and without the stent.The stent was not returned for analysis.The crimped stent outer diameter measured at manufacture was within maximum crimped stent profile measurement.The balloon was reviewed, and it appeared to have been subjected to positive and negative pressure.The distal balloon cone appears to be bunched in a distal direction.The proximal marker band appears to be moved in a proximal direction due to the inner being stretched.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found evidence of stretching along the outer and inner shaft, and port bond site.A shaft break was noted 130cm distal to the distal end of the strain relief.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 3.00 x 38mm synergy ii drug-eluting stent was advanced for treatment.However, during the procedure, the shaft broke.The device was pulled out from the patient's body and the procedure was completed with another of the same device.There were no patient complications reported and the patient was fine.
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Search Alerts/Recalls
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