Block h6: imdrf device code a0401 captures the reportable event of snare loop break.Block h10: investigation results one captivator snare was received for analysis.Visual analysis of the returned device revealed the proximal side of the working length was torn.Also, the wire comes out from the rupture of the working length and the loop could not extend out of the sheath.No other device problems were noted.The reported complaint of loop break was unable to be confirmed since the product analysis revealed the proximal side of the working length was torn and due to this, the wire comes out from the rupture that the working length has, and the loop could not extend out of the sheath, this situation compromises the proper functioning of the device.According to the evidence, one of the possibilities that could have happened was that as part of the use of the device during procedure an excess of force or a bad manipulation was applied to the device causing a burst to the proximal side of the working length and then due to this condition, the loop cannot open correctly.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the reported complaint cannot be confirmed.
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