A complete mfg review could not be performed as the lot number is unk.The device was returned.The investigation is unconfirmed for a device markings issue, as the returned balloon met the spec of a 20mm x 40cm balloon and the balloon hub was marked as a 20mm x 40cm balloon.The balloon met the specs of a 4cm length balloon when measured from the proximal to distal marker bands.The investigation is confirmed for a circumferential balloon rupture.Potential factors which may have caused or contributed to the reported issue have been considered.It is unlikely that the atlas balloon was manufactured to be 6cm in length, as there are no atlas balloons that have a spec of 6cm in length with a 20mm balloon diameter.The length of the balloon body/barrel is measured from the horizontal distance between the cone-to-body transition shoulders of the balloon.The balloon body length does not include the proximal and distal cones.It is unk whether the user was aware that the balloon body length measurement does not include the proximal and distal cones.It is unk if procedural issues contributed to the reported event.The root cause for the balloon rupture could not be determined based upon the available info.
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