Catalog Number SBI080040130 |
Device Problems
Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 07/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician intended to use an admiral xtreme device with a 6fr non-mdt sheath and non-mdt 0.035 guidewire for treatment of a severely calcified lesion in the mid right common iliac artery with little tortuosity.Embolic protection was not used.An non-mdt inflation device was used with contrast and saline.Ifu was followed and no issues were noted during prep.No excessive force used during insertion it is reported that a longitudinal burst occurred during first inflation at 12 atm.Physician went to 8atm then went up to 12atm when balloon burst.It is reported that both markers came off delivery system.Fragments were removed surgically -vessel opened in order to remove detached balloon and 2 platinum iridium markers that had dislodged off the balloon delivery system removed under guidance of image intensifier.Vessel was closed with sutures.Patient is reported as being alive with injury.
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Manufacturer Narrative
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Device evaluation summary: the balloon broke at approximately 1 cm from the proximal balloon welding.The distal part of the balloon was missing.The guidewire lumen underneath the balloon stretched.Signs of proximal marker crimping are still visible.The two markers were missing.The tip was missing.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Angio images provided showed the procedure (guidewire loading, device loading, balloon inflation and device withdrawal).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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