Model Number H7493924215050 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2015 |
Event Type
malfunction
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Event Description
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It was reported that foreign matter was found inside the sterile packaging.During unpacking of the device, a foreign matter "like green textile" was found within the sealed packaging of a guidezilla device.The foreign matter was removed and put on a gauze.The device was used to complete the procedure.No patient complications were reported and patient's status was good.
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Manufacturer Narrative
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Device evaluated by mfr: the product and packaging were not returned for this complaint; however, the ¿green textile¿ foreign matter (fm) was received.The fm was a green color and was bunched-up.The bunched up fm was about 6mm in length.The returned fm was sent to the bsc material testing analysis & characterization ((b)(4)) lab for further analysis.It was determined by (b)(4) that the green foreign material appears to be polytetrafluoroethylene (pfte).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
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Event Description
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It was further reported that the foreign material was found inside the guide segment of the guidezilla once removed from the carrier tube.The procedure was completed with another of the same device.
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Search Alerts/Recalls
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