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Catalog Number AB35W10040135 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 05/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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Two cine images analysis summary: the evercross dilatation catheter was not received for evaluation.No ancillary devices from the procedure were received for evaluation.Two photographic images of cine images were provided.The first image is of the patient¿s left common femoral vein.The evercross dilatation catheter balloon is inflated within two kissing stents.A support catheter is visible in the right common femoral vein.A guidewire runs through the support catheter and evercross dilatation catheter.The second image is of the patient¿s left common femoral vein.The ancillary devices in the patient¿s right common femoral vein have been removed.An ancillary device is seen at the top of the cine image approaching from the abdominal vein.The evercross dilatation balloon chamber appears to be deflated within the kissing stents.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The physician was using an evercross balloon with a non-medtronic 8f sheath and a 0.035 non-medtronic guidewire for treatment of a 200 mm, 70% (stenosed) soft tissue clot in the patient¿s mid left common femoral vein.The vessel diameter was reported to be between 16-18 mm.A non-medtronic inflation device was used with isovue and saline 1:3.The device was prepped without issue.The device did pass through a previously deployed stent.No resistance was encountered nor excessive force used when advancing the device to the lesion.It was reported that the balloon burst at a pressure of 9 atms for 10 seconds on first inflation.The balloon fragments were retrieved with cystograspers and non medtronic catheters were placed bilaterally.No patient injury was reported.
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Search Alerts/Recalls
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