|
(b)(4).Based on the embolic coil damage observed on the returned product, this event meets the required criteria for mdr reporting.Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(6).Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(6)).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an abdominal artery aneurysm, the 2mm x 4cm deltaxsft coil (dlx100204/c40404r) was selected for use as the fifth coil; however, resistance was encountered when the coil was delivered into the prowler lpes microcatheter (unk catalog & lot) and the coil could not be advanced.The coil was subsequently replaced.The procedure was completed successfully without further incident or delay.No patient complications occurred as a result of the event.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.A dcb2 detachment control box was also used for the case.No further information was provided.The 2mm x 4cm deltaxsft coil was returned for investigation.As returned, the coil was partially unsheathed.It was returned inserted through a rotating hemostatic valve (rhv) into a prowler microcatheter.The device was removed from the microcatheter, and it was seen that the embolic coil was completely stretched throughout its entire length.Minimal resistance was felt when pulling the coil from the microcatheter.Dried blood was seen on the embolic coil, in the introducer, and on the device positioning unit (dpu) core wire.The dpu core wire was kinked at approximately 15 cm, 27 cm, and 102 cm from the proximal end.The distal ball tip was present and covered in blood.Blood was present on the embolic coil.The embolic coil was seen stretched from its distal to proximal end.Blood was present in the distal outer sheath over the resistance heating (rh) coil and extended coil sections of the dpu.The articulating joint was compressed longitudinally, and the proximal end of the embolic coil was pressed into the end of the distal outer sheath.The device was significantly kinked on both sides of the marker band; the marker band was also kinked.Blood was seen in both the translucent introducer sheath and green introducer.The v-notch of the resheathing tool was undamaged.Blood was seen in the resheathing tool.Advancement could not be tested because the embolic coil was severely stretched.The prowler select lp microcatheter was not obviously kinked or compressed.An attempt was made to pass a sample guidewire through the microcatheter.The guidewire became impeded approximately 100 cm into the microcatheter and could not be advanced further.There was no obvious external damage to the microcatheter at this location.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint of ¿detachable coil delivery system (dcs) impeded in microcatheter with no loss of cerebral target position¿ could not be confirmed.Advancement of the device could not be tested because the device was returned severely damaged.The returned device was severely stretched, and the articulating joint was compressed.The compression of the embolic coil into the articulating joint is likely to be the result of application of excessive force to the device while attempting to advance the embolic coil in the presence of resistance.Stretching of the embolic coil is generally due to the application of excessive force while attempting to retract the embolic coil in the presence of resistance.Resistance to advancement was noted in the event description, but resistance to retraction was not.Examination of the returned microcatheter demonstrated that resistance to advancement was present.However, there was no obvious damage to the microcatheter that would cause resistance.Resistance may have been caused by insufficient flush.The presence of blood on the embolic coil, in the introducer, and on the dpu suggests that an insufficient flush was maintained.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.100% of devices are inspected for damage to the embolic coil and articulating joint at final assembly.In addition, 100% of devices are inspected for kinks and damage to the dpu at final quality control (qc) inspection.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil or dpu.It is possible that procedural and handling factors, including device manipulation and insufficient flush, may have contributed to the reported event and damages noted on the returned system; however, due to the lack of procedural information and based on the analysis, a definitive root cause conclusion regarding the reported failure cannot be determined.With review of the analysis and the device history records, there is no indication of any device manufacturing issues related to the reported event or the damages found on the returned device.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 events were 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.
|
|
As reported by a healthcare professional, during a coil embolization of an abdominal artery aneurysm, the 2mm x 4cm deltaxsft coil (dlx100204/c40404r) was selected for use as the fifth coil; however, resistance was encountered when the coil was delivered into the prowler lpes microcatheter (unk catalog & lot) and the coil could not be advanced.The coil was subsequently replaced.The procedure was completed successfully without further incident or delay.No patient complications occurred as a result of the event.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush was maintained.No visible product damage was noted prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.A dcb2 detachment control box was also used for the case.No further information was provided.
|
|
Product complaint # (b)(4).The prowler microcatheter was shipped to the physical manufacturer for further investigation.The non-sterile prowler lpes was received inside of a pouch.The hub was inspected, and residues of dried blood were observed.The body of the catheter was inspected, and a compression was noted 18 centimeters (cm) from the distal end.Dried blood was noted on the distal tip of the microcatheter.No additional damage was observed.The microcatheter was inspected under microscope.The compressed condition and dried blood noted at the distal tip during visual analysis was confirmed.An attempt was made without success to flush the microcatheter with a sample syringe.A.018¿ sample guidewire was then introduced into the microcatheter and advanced but became stuck in the body of the microcatheter.The inner diameter (id) and outer diameter (od) were measured and found within specification.The sterile lot number was not reported; therefore, a review of the manufacturing documentation could not be performed.The reported customer complaint ¿catheter (body/shaft)/ obstructed-in patient with no mc loss of cerebral target position¿ was confirmed during functional analysis.The sample guidewire became stuck in the body of the microcatheter during advancement.The failure experienced by the customer may have been related to the compressed section noted on the distal end of the received device.Based on there being no report of damage from the user and the compressed section was not detected during preliminary investigation, it appears that this condition, which would be readily evident to the user, likely occurred during preparation for shipment.However, the exact circumstances surrounding the observed damage to the catheter cannot be determined based on the condition of the returned device.100% of devices are inspected in-process for damage.In addition, 100% of devices are further inspected for visible damage after pouching per the same procedure.Thus, it is very unlikely that the device left the manufacturing facility with the observed compression.The presence of dried blood in the microcatheter suggests that an insufficient flush was maintained.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.Based on the limited information available for review and the analysis of the returned product, a definitive root cause conclusion cannot be determined; however, it is possible that procedural and handling factors, including device manipulation and insufficient flush, may have contributed to the reported event.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.
|
