This event was reported to codman cnv on (b)(6) 2017; however, did not meet mdr reporting criteria until(b)(6) 2017 when the analysis was completed.Conclusion: the deltaplush was returned for analysis.As viewed through the returned packaging, unreported and visible entanglement and damage of the coil around the dpu and sheath was found.A portion of this damage was due to post-procedural mishandling, cleaning, and packaging.Unreported and visible kinks on the dpu located 36.5 and 42.5 centimeters were found.Unreported and visible damage of the sheath being severe was found 7.0 centimeters off the proximal end for a length of 1.5 centimeters.There was unreported buckling of the grey tip coil section, and unreported damage to the proximal end of the resistive heating coil section at the tapered end.The coil¿s socket ring has been severely bent.The proximal section of the coil has compression and buckling damage.The resheathing tools v notch has been severely fractured with a portion of the sheath still protruding through.No manufacturing defects were found.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the resistance inside the microcatheter was not confirmed.Without the return of the headway microcatheter, due to unreported damages to the unit, and due to post-procedural handling, cleaning, and packaging that may have produced additional damages, the exact root cause of the resistance inside the microcatheter cannot be determined; however, the evidence as returned highly suggests that the primary contributing factor may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which may have bent the dpu, buckled the tip coil and resistive coil sections, bent the coil¿s socket ring and damaged the coils proximal section.In this condition severe resistance will be encountered when advancing the coil.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.Grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger.Caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1in.(2-3cm).¿ since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 3 mdrs being submitted for this complaint, with associated report numbers of 2954740-2017-00105, 2954740-2017-00104 and 2954740-2017-00103.
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As reported by a healthcare professional, a physician felt strong resistance during advanced a deltaplush (cpl10015330/ c40127), a deltapaq (cdf10020430/ c33041) and a presidio (pc410073030/ c41431) through a headway 17 microcatheter.Upon return of the devices for analysis, the deltaplush and deltapaq coils were found to be compressed and buckled and the presidio coil was stretched.Other coils were able to be advanced.The physician replaced the coils with same like products and the procedure was successfully completed.There were no potential adverse events.After multiple attempts to obtain additional information, no additional information was provided.
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