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This met mdr reporting criteria on 01 nov 2017 when during product analysis it was found that the coil was kinked and stretched.Procode: krd/hcg.Concomitant medical products: two guidewires (chikai, asahi intecc and radifocus gt, terumo), a guiding catheter (axcelguide, medikit) and a micro catheter (sl10, stryker) were also used for this procedure.(b)(6).(b)(4).As reported by a healthcare professional, during coil embolization of a dual arteriovenous fistula, there was resistance during advancement of six deltaxtrasoft coils (dlx100206/ 3 of s12133 and 3 of s12220) through a stryker sl10 microcatheter.The patient was a male, age unknown.The patient¿s vessel was moderately torturous and not calcified.Two guidewires (chikai, asahi intecc and radifocus gt, terumo), a guiding catheter (axcelguide, medikit) and a micro catheter (sl10, stryker) were also used for this procedure.The deltaxtrasoft devices were all prepared per the instructions for use (ifu) and inserted into the microcatheter; however, there was resistance felt and they could not be advanced.It was unknown how the procedure was completed; however, the procedure was successfully completed without further issues.There was also no patient injury / complication reported.The complaint products were 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 or after the event.No unintended detachment was observed in the vessel or in the microcatheter.It was initially reported that three products of lot s12133 would not be returned for the investigation and three products of lot s12220 would be returned for the investigation; however, it was later reported that four devices would be returned, of uncertain lots.No further information was available.Four devices were returned comingled and with no packaging.Devices are not directly marked with lot number or otherwise individually identified, so they will be evaluated together.Devices are identified as device a, device b, device c, and device d and have been labeled as such.Device a: the device was returned fully sheathed.The distal end of the embolic coil is located near the distal end of the green introducer.There is a severe kink in the translucent introducer sheath where it exits the resheathing tool at the v-notch.There are no apparent kinks or bends in the device positioning unit (dpu) core wire.The ball tip is intact.There are no kinks or stretched sections of embolic coil.The articulating joint and resistance heating (rh) coil are obscured by the green introducer.There is damage to a portion of the translucent introducer sheath.Although difficult to visualize, the translucent introducer sheath feels flattened to the touch at the location where the damage can be seen.The v-notch of the resheathing tool is undamaged.Advancement of the embolic coil through the green introducer was attempted.The device could not be advanced through the introducer, but it could be retracted.The device was retracted until the articulating joint and rh coil were located in the translucent introducer sheath.Under microscopy, the articulating joint appears to be damaged.When pressure is applied to advance the embolic coil, the proximal section of the embolic coil compressed, but the distal section stays relaxed.The embolic coil was gently removed from the introducer.After being removed from the introducer, the articulating joint can be observed to be damaged.No kinks or stretched sections can be observed in the embolic coil after it was removed from the introducer.Device b: the device was returned fully sheathed.The distal end of the embolic coil is located near the distal end of the green introducer.There are no apparent kinks or bends in the dpu core wire.The ball tip is intact.There are no kinks or stretched sections of embolic coil.The articulating joint and rh coil are obscured by the green introducer.There is some damage to the translucent introducer sheath.Advancement of the embolic coil through the green introducer was attempted.The device could not be advanced through the introducer, but it could be retracted.The device was retracted until the articulating joint and rh coil were located in the translucent introducer sheath.Under microscopy, the articulating joint appears to be damaged.When pressure is applied to advance the embolic coil, the proximal section of the embolic coil compressed, but the distal section stays relaxed.The embolic coil was gently removed from the introducer.After being removed from the introducer, the articulating joint can be observed to be damaged.No kinks or stretched sections can be observed in the embolic coil after it was removed from the introducer.Device c: the device was returned sheathed.The embolic coil protrudes through the skive of the translucent introducer sheath.There is a severe kink in the translucent introducer sheath where it exits the resheathing tool at the v-notch.There are no apparent kinks or bends in the dpu core wire.The ball tip is intact.The proximal end of the protruded embolic coil is stretched, kinked, and bent over on itself.The articulating joint has been destroyed.The v-notch of the resheathing tool is undamaged.The translucent introducer sheath is kinked where it exits the resheathing tool.Advancement cannot be attempted because the embolic coil protrudes from the skive of the translucent introducer sheath and is no longer connected to the dpu.Device d: the device was returned fully sheathed.The embolic coil is located in the translucent introducer sheath.There are no apparent kinks or bends in the dpu core wire.The ball tip is intact.The embolic coil is kinked and stretched.The articulating joint is damaged.Advancement cannot be attempted because of the damage to the embolic coil and articulating joint.A review of manufacturing documentation associated with both lots presented no issues during the manufacturing or inspection processes related to the reported complaint.For all four devices, the complaint that the device was impeded in the microcatheter cannot be confirmed.Because the devices could not be advanced out of the introducer, advancement through a microcatheter could not be attempted.Damage was observed on all four devices that is indicative of application of excessive force.All four devices exhibit damage to the articulating joint.The coils of devices a and b could not advance through the introducer because of the damage to the articulating joint.When manufactured, the two components of the articulating joint are aligned.Pressure from the dpu side of the joint is translated into motion of the embolic coil straight through the introducer.In this case, the embolic coil is slightly offset and angled away from the joint.Pressure from the dpu side of the joint is translated into motion of the embolic coil towards and against the wall of the introducer, creating friction and impeding progress.100% of devices are inspected in-process for the ability to advance through the introducer and retract back.Damage to the articulating joint sufficient to prevent advancement of the embolic coil would be observed at this inspection.Thus, it is unlikely that the observed issue was present when the devices left the manufacturing facility.In addition to articulating joint damage, devices c and d also exhibit damage to the embolic coil.In device c, the embolic coil is stretched, kinked, bent over on itself inside the translucent introducer sheath, and protruding from the skive of the translucent introducer sheath.The articulating joint of device c is destroyed.It is likely that the resheathing tool of device c was advanced over the embolic coil 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 inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil will be unsheathed and pass through the resheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.In device d, the embolic coil is kinked and stretched inside the translucent introducer sheath.100% of embolic coils are inspected for damage, so it is unlikely that the damage to the embolic coils of devices c and d occurred before the units left the manufacturing facility.Devices a, c, and d have severe kinks in the translucent introducer sheath where it exits the resheathing tool.In addition, the kinks in the translucent introducer sheath suggest that the device was not unsheathed carefully.According to the ifu, the introducer sheath is unlocked by gently pulling it away from the resheathing tool at a 45-degree angle.Pulling at a greater angle, or fully bending or kinking the translucent introducer sheath, will damage the sheath in such a way that it cannot re-form as it passes back through the resheathing tool during resheathing.The exact sequence of events is unknown, and packaging and shipping materials were not returned, so it cannot be determined whether the damage to the devices occurred in transit, during storage, or when prepared or used for the procedure.There is no current safety signal identified related to the reported event based on review of complaint histories for the devices.Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
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As reported by a healthcare professional, during coil embolization of a dual arteriovenous fistula, there was resistance during advancement of six deltaxtrasoft coils (dlx100206/ 3 of s12133 and 3 of s12220) through a stryker sl10 microcatheter.The patient was a male, age unknown.The patient¿s vessel was moderately torturous and not calcified.Two guidewires (chikai, asahi intecc and radifocus gt, terumo), a guiding catheter (axcelguide, medikit) and a micro catheter (sl10, stryker) were also used for this procedure.The deltaxtrasoft devices were all prepared per the instructions for use (ifu) and inserted into the microcatheter; however, there was resistance felt and they could not be advanced.It was unknown how the procedure was completed; however, the procedure was successfully completed without further issues.There was also no patient injury / complication reported.The complaint products were 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 or after the event.No unintended detachment was observed in the vessel or in the microcatheter.It was initially reported that three products of lot s12133 would not be returned for the investigation and three products of lot s12220 would be returned for the investigation; however, it was later reported that four devices would be returned, of uncertain lots.No further information was available.
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