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Model Number PXSLIMLAN135T45 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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Event Description
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The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using a lantern delivery microcatheter (lantern), ruby coils, and a non-penumbra catheter.It should be noted that the patient's anatomy was tortuous.During the procedure, one ruby coil was successfully implanted into the target location.Next, the physician encountered resistance while advancing a ruby coil in the middle of the lantern.The ruby coil was retracted and re-advanced; however, the same issue occurred.Therefore, the lantern was removed.The procedure was completed using another lantern to implant the same ruby coil and six additional ruby coils.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Evaluation of the returned lantern revealed a functional device.During functional testing, a demonstration ruby coil was able to be advanced through the lantern without an issue; therefore, reported complaint could not be confirmed.Further evaluation of the device revealed a distal shaft ovalization.If the device is forcefully pinched or gripped during use, damage such as this may occur.Based on the location of the damage, this damage was likely incidental to the complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
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Search Alerts/Recalls
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