Catalog Number NCEUP4015X |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
Intimal Dissection (1333)
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Event Date 11/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device returned with balloon folds open and residue present inside the balloon indicating that it had already been inflated.The device failed negative prep.On pressurisation of the device, a leak was observed on the proximal section of the balloon.There was a short longitudinal tear on the proximal balloon working length.The balloon material was jagged, uneven and raised at the tear site.The distal shaft was kinked 8.2cm distal to the guidewire entry port.There was deformation to the distal tip.Still cine image review: four still cine images were received.The first still cine images confirm the lesion site in the rca as reported by the account.The next images capture the inflation of the nc euphora balloon at the lesion site.The final image captures the guidewire and the two marker bands with what appears to be the burst balloon.There is no evidence of a dissection from the cine images.(b)(4).
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Event Description
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It was reported that the physician was attempting to use a nc euphora balloon.The target lesion was in the rca : tubular eccentric 80% ln of proximal rca, ulceration.No damage noted to device packaging.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The device was being used to post-dilate a deployed 3.5 x 23mm stent.It was reported that a balloon rupture occurred during a subsequent balloon inflation before rbp at 12 atm.When (b)(6) was done, a proximal edge dissection was noted.The device was not moved or repositioned prior to the burst.The physician completed the procedure with an unknown brand device.Patient status post procedure is alive - no injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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