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Model Number PXSLIMLAN135T45 |
Device Problems
Failure to Advance (2524); Physical Resistance/Sticking (4012)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2020 |
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.
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Event Description
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The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a pod coil and a lantern delivery microcatheter (lantern).It was noted that the patient's anatomy was tortuous.During the procedure, while advancing the pod coil halfway through the microcatheter, the physician experienced resistance and had difficulty advancing the pod coil further; therefore, the pod coil and lantern were removed.The procedure was completed using three other coils and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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