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(b)(4).Procode: krd/hcg.(b)(4).Concomitant med products due to character limitation: 6f envoy (67025800/3003521) guiding catheter, prowler-14 dual marker (606151x/30016814) infusion catheter, neuroscout 14 (601314/hn3960) steerable guidewire, neuroscout 14 (601314/hu5767) steerable guidewire.The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.(b)(4).The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
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As reported by a healthcare professional, the 3mm x 6cm cashmere 14 (crc14030630/s12842) thermo-mechanical coil failed to detach during the procedure.The coil was successfully removed from the patient without need for additional intervention and replaced to complete the procedure.There was no report of consequence or impact to the patient.The surgery was not delayed due to the event.The product was prepped and used according to the instructions for use (ifu).The user did not change the connecting cable and/or detachment control box (dcb) during the reported event.The user reportedly attempted to perform the pre-deployment electrical check but did not succeed (pending clarification).The embolic coil was still attached to the delivery system when removed from the patient and no damage was noted to the embolic coil.A 6f envoy (67025800/3003521) guiding catheter, prowler-14 dual marker (606151x/30016814) infusion catheter, neuroscout 14 (601314/hn3960) steerable guidewire, and a neuroscout 14 (601314/hu5767) steerable guidewire were also used in the case.The complaint product will be returned for evaluation.No further information was provided.
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Product complaint # (b)(4).Section b5 - inspection of the returned device revealed foreign material, which was found surrounding the embolic coil within the introducer.Additional information received from the affiliate indicated that the device contamination was not evident prior to the procedure or upon removal from the patient.The user did not encounter resistance/friction while withdrawing the coil into the introducer.[complaint conclusion]: as reported by a healthcare professional, during a coil embolization procedure, the 3mm x 6cm cashmere 14 (crc14030630/s12842) coil failed to detach during the procedure.The coil was successfully removed from the patient without need for additional intervention.The coil was replaced to complete the procedure.There was no report of consequence or impact to the patient.The surgery was not delayed due to the event.The product was prepped and used according to the instructions for use (ifu).The user did not change the connecting cable and/or detachment control box (dcb) during the reported event.A pre-deployment electrical check was performed successfully prior to use on the patient.The embolic coil was still attached to the delivery system when removed from the patient and no damage was noted to the embolic coil.No further information could be obtained.The 3mm x 6cm cashmere 14 was returned for evaluation.The embolic coil was measured to be approximately 6 cm, which aligns with the length of the reported product.Upon receipt of the device, visual inspection was conducted.The device positioning unit (dpu) core wire was seen protruding from the introducer skive.The dpu core wire passed through the distal end of the resheathing tool outside the introducer sheath.The device positioning unit (dpu) core wire was seen with a minor bend at the proximal end of the strain relief valve.The dpu core wire was kinked at approximately 41 cm from the proximal end of the device.The device was then inspected under a microscope.The embolic coil distal ball tip was present and intact.The proximal end of the embolic coil was kinked, and the socket ring had been pressed into the distal outer sheath, damaging the articulating joint.The skive was seen widened at the area where the dpu core wire protruded from it.The v-notch of the resheathing tool was seen undamaged.Foreign material was observed in the introducer.The skive had been widened in order to observe the articulating joint area better.The distal outer sheath did not appear to have been softened, indicating that the detachment process had not been initiated.Foreign material was seen surrounding the articulating joint area.The resistance of the device was measured with lab multimeter.Resistance measurement returned an open loop result, which is outside of the specification range.The device was inspected, but location of external circuit damage could not be found.The device was connected to lab sample enpower detachment control box c38341 and enpower control cable c10702.The power was turned on, but the ¿system ready¿ light failed to illuminate.The detachment cycle could not be initiated.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 nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The customer report of failure to detach was confirmed.While measuring the resistance, an open loop in the electronic circuit was discovered in the device and the ¿system ready¿ light of the dcb did not illuminate when connected.Therefore, the detachment process could not be initiated in the product analysis lab.The cause of the open loop in the electronic circuit cannot be clearly established; however, it is likely that the kink in the dpu core wire may have contributed to the event.Kinks in the dpu are possible sources of damage to the circuit.There was no other external damage found that could potentially be the source of the open loop.100% of embolic coils and dpu core wires are inspected in-process for damage and resistance is verified to be within specification.Thus, it is unlikely that the device left the manufacturing with the observed damage or with an open loop in the circuit.Without the return of the concomitant connecting cable and dcb, the cause of the reported event cannot be determined.Failure to detach is a known potential product failure associated with the use of the device.The ifu contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Per the ifu: ¿verify that the microcoil delivery system is fully connected, and no faults are indicted on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil, and replace with a new microcoil system.If the system is free of faults, depress the detach button on the blue enpower dcb, the black dcb or the enpower control cable.The detach cycle light next to the button will illuminate and an intermittent tone will sound for the duration of the detachment cycle.If the light and audible tone do not activate, replace the dcb.¿ neither the product analysis nor the device history record review suggests that the failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure to detach and damages noted on the returned system.A sample of the foreign material was sent to advanced sterilization products (asp) to be ft_ir analyzed.The results found that the majority of the material was comprised of nylon, which is a common synthetic polymer.The unknown material composition could not be assessed as there was no suspected source of contamination.The additional information provided by the affiliate confirmed that no device contamination was evident upon removal from the patient and no resistance was encountered during device withdrawal.The material found in the complaint unit would have caused resistance during extraction of the device.Therefore, it is likely that the foreign material was introduced to the device following the procedure.There are checks in place during manufacturing that require inspection of the device for contamination.A contaminated device with this quantity of foreign material would not have passed manufacturing inspections.Thus, it is very unlikely that the device left the manufacturing facility with the observed contamination.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
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