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Catalog Number RBYPOD6 |
Device Problems
Physical Resistance/Sticking (4012); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned and the investigation results are pending.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 internal iliac artery (iia) using pod coils, a non-penumbra microcatheter, and an angiographic catheter.It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician encountered resistance while advancing a pod coil in the middle of the microcatheter and the coil became stuck.Upon retraction, resistance was also encountered and, subsequently, the pod coil unintentionally detached inside the middle of the microcatheter.Therefore, the microcatheter containing the detached pod coil was removed and the pod coil was flushed out on the back table.The procedure was completed using the same microcatheter to successfully implant seven ruby coils into the target location, and a stent-graft was also used.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 pod coil confirmed that the embolization coil was detached from its pusher assembly.Evaluation revealed that the pet lock was intact, and the pull wire was within its original position.If the pod coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire, and result in the embolization coil detaching from the pusher assembly.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra products are visually 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.
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Search Alerts/Recalls
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