Model Number 10604 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Event date: estimated based on aware date of (b)(6) 2020.Device is a combination product.
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Event Description
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This device was received with a note written on the box "defective- fuzz on stent straight out hoop".However, upon review of the device, it was revealed that a foreign material was present on the device.
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Event Description
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This device was received with a note written on the box "defective- fuzz on stent straight out hoop".However, upon review of the device, it was revealed that a foreign material was present on the device.
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Manufacturer Narrative
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B3: event date - estimated based on aware date of (b)(6) 2020.Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.75 x 24 mm stent delivery system catheter was returned for analysis coiled in its hoop.The hoop was enclosed within an opened shelf carton.Some creasing damage was noted to box and the seal was open.Written in marker on the box was: '* defective * fuzz on stent straight out of hoop.' when withdrawing the device from the hoop a piece a fibrous fm (foreign matter) was noted and it was not attached to the hoop or the device.The fibrous fm was white in color and approximatively 3mm in length.The fm was placed in a labeled container and awaits ftir testing.No product mandrel or stent protector was returned with the device.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The 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 tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.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.The sample was compared to a library of samples from the data base of the material characterization lab including different materials present in the des manufacturing cleanroom however no matches were found.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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