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Catalog Number RBY2C4060 |
Device Problems
Mechanical Jam (2983); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2018-02063.
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Event Description
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The patient was undergoing a coil embolization procedure to treat an abdominal aortic aneurysm (aaa) using a lantern delivery microcatheter (lantern) and a ruby coil.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician had difficulty advancing a lantern up to the target vessel but ultimately was able to advance it.While attempting to advance a ruby coil through the lantern, the physician experienced resistance and the ruby coil became stuck inside the lantern; therefore, both lantern and ruby coil were removed.The procedure was completed by placing a stent device over the aneurysm and a vascular grafts within the common femoral into the aorta.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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