INGEVITY MRI active fixation pacing leads 의 안전성 경고

Safety alert

2017-09-26

2017-09-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170926.html

Medical device safety alert: boston scientific ingevity mri active fixation pacing leads medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its ingevity mri active fixation pacing lead [part number: 358659-061]. the manufacturer has received complaints of helix deployment difficulty (e.G., inability to extend or retract the helix) with the ingevity active fixation lead during surgical implantation. this behaviour is highly detectable and can be resolved without any adverse health consequences. helix deployment difficulties are attributed to severe bending due to challenging anatomy, proximal bending during activation of the terminal pin, and/or rapid rotation of the terminal pin (e.G. rotating terminal pin faster than one turn per second). typically, the behaviour is overcome using techniques described in the existing ingevity physician’s lead manual (plm) or by implanting a new ingevity lead. if the lead’s terminal pin is rotated in excess of the maximum number of thirty turns, an acute conductor coil break may result. based on detailed laboratory analysis of returned ingevity leads associated with reported helix deployment difficulty, the manufacturer has confirmed all conductor coil breaks observed to date have occurred acutely during surgical implantation or revision procedures. no latent ingevity coil breaks have occurred due to helix deployment difficulty; however, in some cases the break was not identified until the pocket was closed due to delayed pg testing, which has led to a revision procedure. significant analysis of the performance of the ingevity active fixation pacing lead has shown that the clinical consequences associated with helix deployment difficulty during implant procedures are consistent with patient safety and risk expectations. the frequency of this behaviour is reduced if plm instructions are followed. the potential risk to patient safety from helix deployment difficulty is very low and within the design risk analysis, as it occurs during an implant or revision procedure when remedial action can be implemented. according to the manufacturer, the french national security agency of medicines and health products (ansm) has requested that the manufacturer communicate directly to pacing lead implanters in france. the fsn is intended to ensure their awareness of these plm updates and the potential outcomes if instructions are not observed. the updates do not change the way the lead is used according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 september 2017.