Catalog Number AB35W06100080 |
Device Problems
Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
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Patient Problems
Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
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Event Date 03/21/2019 |
Event Type
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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Event Description
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The physician was attempting to use an evercross balloon to treat an av fistula.There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped with per ifu with no issues.Six inflations were performed.It was reported that during balloon inflation to 18atm the balloon burst.During removal of the device from the patient, the distal marker detached from the device and remained in the patient.The balloon was removed from the patient.
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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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Manufacturer Narrative
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Additional information: no attempts were or will be made to remove the detached portion.The patient is safe and experiencing no adverse effects due to this.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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