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(b)(4).This initial/final mdr will be the only report submitted for mfr report #3008114965-2018-00658.The initial reporter information has not been provided.(b)(4).Conclusion: two devices were returned commingled.The embolic coil of one device is partially advanced out of the introducer and tangled around the device positioning units (dpus).The embolic coil of the other device is located in the introducer.The two devices on the complaint can be distinguished by length, and the lengths of the two returned devices can be measured.The devices were temporarily identified as device a and device b.The two devices were carefully disentangled, and the lengths of the embolic coils were measured with a ruler.Device a: the embolic coil of device a is approximately 30 cm long.The embolic coil is partially advanced out of the introducer.The device is mostly sheathed.The resheathing tool is broken.The dpu core wire is kinked approximately 9 cm, 32 cm, 47 cm, 61 cm, 72 cm, 76 cm, 93 cm, 113 cm, and 114 cm from the proximal end.The ball tip is intact.The embolic coil is not kinked or stretched.The articulating joint is aligned.The articulating joint may be compressed longitudinally, but the green introducer obscures the condition.The condition of the resistance heating (rh) coil is also obscured by the green introducer.The dpu core wire does not protrude through the skive of the translucent introducer sheath.While the resheathing tool is broken, its v-notch is undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the introducer is cracked or damaged is not confirmed.No part of the dpu protrudes from the skive of the translucent introducer sheath, even in locations where the dpu core wire is kinked.In addition, there is no other observable loss of integrity in the structure of the introducer.The resheathing tool is broken and there are several severe kinks in the dpu core wire.Both circumstances are evidence of the application of excessive force to the device.The severity of the damage to the dpu core wire suggests that it may have occurred after the device was removed from use, especially since kinking was not documented in the event description with respect to this device.Device b: two devices were returned commingled.The embolic coil of one device is partially advanced out of the introducer and tangled around the device positioning units (dpus).The embolic coil of the other device is located in the introducer.The two devices on the complaint can be distinguished by length, and the lengths of the two returned devices can be measured.The devices were temporarily identified as device a and device b.The two devices were carefully disentangled, and the lengths of the embolic coils were measured with a ruler.The embolic coil of device b is approximately 26 cm long.The distal end of the embolic coil is located in the translucent introducer sheath, near the green introducer.The extended coil, marker band, and soft distal end of the dpu core wire protrude from the skive of the translucent introducer sheath.The device is partially unsheathed.There is a bend in the dpu core wire approximately 77 cm from the proximal end.The distal end of the green introducer is severely damaged.It appears to be split longitudinally and spread open.The ball tip is intact.The embolic coil is kinked.The articulating joint is intact.The condition of the resistance heating (rh) coil is obscured by the translucent introducer sheath.At the distal end of the protrusion, the extended coil section of the dpu passes out of the skive of the translucent introducer sheath.At the proximal end of the protrusion, the dpu core wire passes into the skive.The v-notch of the resheathing tool is undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the device is kinked or bent is confirmed.The dpu core wire is bent.The bend in the dpu core wire may have occurred when excessive force was applied in an attempt to overcome resistance.Two sources of resistance are observed in the returned device.The embolic coil is kinked, which can create resistance.No cause of the kink in the embolic coil can be observed in the returned device.However, 100% of devices are inspected at quality control (qc) final inspection for damage.In addition, 100% of devices are inspected at final assembly by advancing the embolic coil out of the introducer and retracting it back in.Thus, it is very unlikely that the device left the manufacturing facility with the observed kink in the embolic coil.The second source of resistance identified in the returned device is the protrusion of the soft distal end of the dpu from the skive of the translucent introducer sheath.It is likely that the resheathing tool was advanced over the extended coil of the dpu while unsheathing the device.The ifu instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.Attempts to advance the device with the soft distal end of the dpu exposed result in further kinking rather than advancement of the embolic coil.The cause of the damage to the distal end of the green introducer cannot be identified from the condition of the returned device.However, 100% of devices are inspected at qc final inspection for the condition of the introducer per the above referenced procedure, so it is very unlikely that the device left the manufacturing facility with the observed damage.There is no current safety signal identified related to the reported events based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.
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It was reported by a healthcare professional that a micrusframe10 (mfr100626/s13146) was used during a post-evar coil embolization procedure of a type 2 endoleak aneurysm when the delivery wire was bent and the coil could not be advanced.The femoral artery was punctured by 5fr sheath, then the guiding catheter (5fr, imager) and the microcatheter (corsair pv, asahi intecc) were advanced to the ima.Coil embolization began and a micrusframe18 was attempted to be used for the third coil, but the coil introducer split and the coil could not be delivered.The coil was replaced with another one.After approximately 4 coils were used, the vessel diameter had become thinner and a micrusframe10 s was selected.When the wire was advanced into the introducer, the delivery wire was bent and it could not be advanced at all.The coil was replaced with another one.A dcb2 were also used for this procedure.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The products will be returned for the investigation.No further information is available.Note: this event was deemed mdr reportable based on device evaluation findings.
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