BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number 86705 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported that a dynamic xt catheter was found to have filaments of "suspected origin" on the catheter.There was no procedure involved.
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Manufacturer Narrative
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Visual inspection of the device and packaging showed the cardboard package and the protective tube showed damages.Inside the pouch of the returned the device what seemed to be a hair was found in the distal end of the pouch, trapped in the heat seal, consequently, it confirms the reported complaint.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.
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Event Description
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It was reported that a dynamic xt catheter was found to have filaments of "suspected origin" on the catheter.There was no procedure involved.
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Search Alerts/Recalls
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