Catalog Number ADM080060130 |
Device Problems
Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
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Patient Problem
Extravasation (1842)
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Event Date 04/08/2015 |
Event Type
Injury
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Event Description
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The physician was attempting to use an admiral xtreme balloon to treat an av fistula.The lesion exhibited very little tortuosity, calcification, lesion or stenosis.No abnormalities noted during preparation and inspection of the admiral xtreme device prior to use.No difficulty noted when loading the device onto guidewire.No resistance noted during delivery of the device to lesion.During the first inflation the admiral xtreme was inflated to 14 atm for approximately 15 seconds in the av fistula and the balloon burst (balloon appeared to burst circumferentially).Upon removal the balloon got caught on the sheath and was pulled out with force.The balloon shaft was broken.Sheath and all the balloon pieces were removed with a kelley clamp and replaced with a 7 f sheath.Angiogram showed a small amount of extravasation at the balloon site.Md used another 8 x 60 admiral inflated to 4 atm and extravasation disappeared.Md used an 8mm x 2cm cm balloon to further dilate lesion.Procedure completed successfully.No further clinical sequelae reported.
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Manufacturer Narrative
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Evaluation results: (based on information received root cause is undetermined).No results available since no evaluation performed - (device or procedural images not provided for review).(no device received for evaluation).Inherent risk of procedure ¿ (dissection).Evaluation conclusion: (based on information received root cause is undetermined).Unable to confirm complaint ¿ (device or procedural images not provided for review).Inherent risk of procedure ¿ (dissection).(b)(4).
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Manufacturer Narrative
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Evaluation results: related to operational context - event most likely procedural related, no issues noted during device inspection and preparation prior to use evaluation conclusion: operational context caused or contributed to the event - event most likely procedural related, no issues noted during device inspection and preparation prior to use.
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Search Alerts/Recalls
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