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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The patient was undergoing a coil embolization procedure in the thyrocervical, left internal mammary artery (lima), and venous collateral using packing coil lps and a non-penumbra microcatheter.During the procedure, while advancing a packing coil lp into the target location, the physician experienced resistance and the microcatheter would kick back out of the vessel.When the physician went to retract the packing coil lp, there was resistance noted and the coil had unintentionally detached inside the microcatheter.The physician removed the microcatheter containing the detached packing coil lp and a new microcatheter was placed in the vessel.Next, while advancing another packing coil lp into the vessel, the physician noticed the packing coil was too stiff.Therefore, the packing coil lp was removed and saved for later to be use in a different vessel.When the physician attempted to reuse the packing coil lp in a different collateral vessel, the physician experienced resistance and the coil would not advance out from its introducer sheath; therefore, the packing coil lp was removed.The physician then advanced a third packing coil lp into the vessel, but the coil was stiff and the microcatheter would kick back out from the vessel.The packing coil lp was removed.The procedure was completed using new non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
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