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Model Number PXSLIMLAN135T45 |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2021 |
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 ovarian vein using a lantern delivery microcatheter (lantern) and a non-penumbra diagnostic catheter.It was noted that the patient¿s varicose veins were tortuous.During the procedure, while advancing the lantern through the diagnostic catheter and into the varicose of the ovarian vein, the physician experienced resistance.Subsequently, the physician kinked the distal end of the lantern.Therefore, the lantern was removed.The procedure was completed using a non-penumbra microcatheter and the same diagnostic catheter.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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