W.L. GORE & ASSOCIATES AORTIC INTRODUCER SHEATH (DRYSEAL FLEX VER 4.0); INTRODUCER, CATHETER
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Catalog Number DSF2433 |
Device Problem
Off-Label Use (1494)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 12/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Per the gore® dryseal flex introducer sheath instructions for use, the nominal body outer diameter of a 24fr sheath is 8.8mm.The ifu states ¿if vessel size is smaller than the nominal body outer diameter, major bleeding, vessel damage, or serious injury to the patient, including death, may result.¿.
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Event Description
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On (b)(6) 2018, a 24fr gore® dryseal flex introducer sheath was used as part of a thoracic endovascular aortic repair.According to the report, resistance was felt in the left femoral artery (measuring 5.6 mm - 5.9 mm in diameter), and the sheath could not be advanced.The physician dilated the left femoral and left external iliac arteries with a balloon, and the sheath was successfully advanced to the intended position.After two endoprostheses were advanced and implanted, the sheath was removed from the patient.Upon withdrawal, it reportedly appeared that the left femoral artery was damaged near the sheath insertion site.No decrease in blood pressure was observed.The lesion in the left femoral artery was surgically repaired, and the patient tolerated the procedure.
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Search Alerts/Recalls
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