A visual and functional inspections were performed on the returned device and the reported leak was confirmed via sem analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.Possible factors that can contribute to hub leak include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, insufficient/delamination of the adhesive at the inflation lumen/sidearm junction, accessory devices or loose connection with the inflation device.It should be noted that the instructions for use (ifu), pta, armada 35 / armada 35 ll, global, ce, costa rica states: express all air and leave the catheter under negative pressure until the balloon is at the target lesion site.Additionally, place the prepared catheter over a pre-positioned guide wire and advance the tip to the introduction site.In this case the reported ifu violation did not cause or contribute to the reported hub leak.Based on the sem analysis, the investigation has determined that the reported leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.Addtl mfg narrative.
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H6: device code 2017- failure to follow steps / instructions.A visual and functional inspections were performed on the returned device and the reported leak was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.It should be noted that the armada 35 / armada 35 ll instructions for use (ifu) states: express all air and leave the catheter under negative pressure until the balloon is at the target lesion site.Additionally, place the prepared catheter over a pre-positioned guide wire and advance the tip to the introduction site.In this case the reported ifu violation did not cause or contribute to the reported hub leak.Possible factors that can contribute to hub leak include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, insufficient/delamination of the adhesive at the inflation lumen/sidearm junction, accessory devices or loose connection with the inflation device.The investigation has determined that the reported leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.Na.
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