Model Number M001173010 |
Device Problem
Material Rupture (1546)
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Patient Problems
Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)
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Event Date 12/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Same case as mdr id: 2134265-2017-12581.It was reported that the balloons ruptured and the patient required surgery.The patient presented with bilateral artery occlusion and placenta previa.Two 6-6/2/80 occlusion balloon catheters were advanced into the left and right femoral artery for dilation.No resistance was noted upon inserting the balloon and no imaging was performed as the patient was pregnant.The balloons were inflated to 2 atmospheres and the pressure immediately dropped.The patient was then successfully operated for the delivery of the baby and the balloon catheters were also removed.Upon removal, it was noted that the balloons were split.After the balloons were removed, the patient had a big bleed which prompted an emergency hysterectomy and the patient was on "hdu." no further patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: the unit returned has balloon damaged, as part of overall visual revision.The balloon is burst.The catheter of the device is kinked approximately at 14.5 cm from the balloon hub, close to the bifurcation.Functional testing cannot be performed based on the returned condition of the balloon.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Event Description
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It was further reported that imaging to aid in placement of the occlusion balloons was performed with image intensifier.The balloons were being used to occlude the internal iliac arteries, to provide an a-vascular field for a high risk c-section.The balloons were inflated once before they ruptured.In the opinion of the physician the balloons were not related to the report of "big bleed." the balloons were successfully removed following the c-section.The patient was on a high dependency unit following the procedure.The patient and baby are healthy.
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Search Alerts/Recalls
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