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Balt usa has aligned the united states mandatory reporting process with balt extrusion.Under this improved reporting process, "similar devices" between balt extrusion and balt usa have been defined.All complaints received by balt extrusion and related to such similar devices which are marketed in the united states by balt usa shall be evaluated by balt usa according to mdr requirements.A retroactive analysis was performed on legacy complaint records to identify any prior occurrences deemed mdr reportable.This complaint has been deemed mdr reportable under this program and recorded in the balt usa complaint management system.Balt usa's reference number: (b)(4).Here is the summary of event and investigation as reported by balt extrusion: "medical procedure: endovascular therapy for correction of an avm.Pathology: avm of cerebral vessels patient with a malformation.The magic is positioned.It is washed with 5% dextrose in distilled water previous arteriography through the magic.At the time of injecting histoacryl and 20% lipiodol without resistance, there is leakage of the embolizer 15 cm proximal to the tip.There is occlusion of carotid, middle cerebral artery and anterior cerebral artery.Stroke in the carotid, stroke in the middle cerebral artery and stroke in the anterior cerebral artery because of the leakage of the embolizer in those vessels and subsequent death of the patient." follow up information provided by distributor: "add.Information received on december 11th 2019 by (b)(4) (distributor): could you please tell us what type of syringe was used for the different procedure: during flush of catheter: 1cc thread syringe.During injection of the contrast liquid: 1cc thread syringe.During injection of the embolizer: 1cc thread syringe.Could you please tell us if these syringes are available for the investigation? these syringes are not available because they were discarded once the medical procedure ended taking into account that the protocol talks about saving only the product that presented failures.Could you please tell us if the physician saw the embolizer flowed from the distal part before there was the leakage around the proximal part? no.The contrast agent flowed towards the avm.Could you please tell us if before the injection of embolizer, the user has realized an injection with contrast agent to check the integrity of the catheter? an injection with contrast agent was performed but there was no leak.Do you have pictures of the catheter and/or ct scan of the procedure? the hospital did not send images of the procedure.Could you please tell us if this case has been notified to your local competent authority? if yes, please send us the copy of the notification.As indicated in the report form: it was not notified to the competent authority." the returned device was inspected in our quality laboratory with the support of the engineering teams.During our analysis, we confirmed that the magic microcatheter was ruptured with a ""bubble"" shape on the white pursil tube few centimeters distally from the pink pursil tube.The rupture was not located at the level of the welding between the pink and the white pursil tubes.This damage, with a dilated "bubble shape", is typical of an overpressure and is not due to an excessive tensile.We also observed a glue plug distally from the rupture site when we longitudinally cut the white pursil tube.Other case(s) magic-overpressure with embolic agent + use of 1cc syringe: 2015: 2 ((b)(4)), 2016: 1 ((b)(4)), 2017: 4 ((b)(4)), 2018: 2 ((b)(4)), 2019: 3 ((b)(4)), global: 12 ((b)(4)).Ratio/sales (inc.Free units): (b)(4).All magic microcatheters are 100% controlled with a leakage / pressure test during the manufacturing process.In addition, 2 samplings are tested till bursting as destructive test.The review of the lot history records for this specific product did not highlight any anomaly that could potentially lead to the issue experienced by the physician.There is no similar complaint registered on this lot number to date in our database.In addition, the pressure resistance of the microcatheter magic is validated and this validation demonstrated that the devices cannot burst on the pressure range allowed as per indicated on the label and in the ifu.Based on the data issued from our post-marketing surveillance program, the magic microcatheters ruptures could be explained by an overpressure above the maximum 7-bars limit indicated on the label and in the ifu.This could be explained by a too strong injection that could be potentially linked to the use of an inappropriate syringe size.A 2.5cc minimum syringe shall be used as indicated on the label and in the in the ifu.It has been reported the use of a 1cc syringe during the flushing and the successive injections into the patient body (liquid contrast and glue).The use of a smaller syringe accentuates the pressure increase inside the microcatheter's lumen for mechanical reasons.As clearly indicated on the product label and in the instructions of use: a 2.5cc minimum must be used during to avoid overpressure phenomena and so the risk of catheters rupture during use.In addition, the glue plug observed within the microcatheter's lumen could be explained by a premature solidification of the embolic agent which probably led to the obstruction of the device and which finally accentuated the overpressure phenomena.This issue cannot be related, from mechanical perspectives, to the device magic itself.As mentioned in the instructions of use: "the procedure must be stopped and the microcatheter removed immediately if any resistance occurs during the injection".In conclusion, based on the there is no technical link between the device itself and the failure observed.The most probable root-cause of the incident is related to the use of an improper syringe size potentially associated to the premature solidification of the embolic agent.05/12/2019 dhr analysis: ctrl 8/9 and 10: welding ps rose / ps white: on 30/1/19 - 0 rebut.Ctrl 25: 7 bars: le1 / 02/2019 - 0 rebut no deformation or leakage.Ctrl 26: 100% visual ctrl: 2/02/2019 - 2 rebuts.Ctrl 32: 2 test and exploded samples at 20 bars and 21 bars on 02/05/2019.No nc number on this dhr.No rc for magic manufactured the same week.
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It was reported that: "medical procedure: endovascular therapy for correction of an avm.Pathology: avm of cerebral vessels patient with a malformation.The magic is positioned.It is washed with 5% dextrose in distilled water previous arteriography through the magic.At the time of injecting histoacryl and 20% lipiodol without resistance, there is leakage of the embolizer 15 cm proximal to the tip.There is occlusion of carotid, middle cerebral artery and anterior cerebral artery.Stroke in the carotid, stroke in the middle cerebral artery and stroke in the anterior cerebral artery because of the leakage of the embolizer in those vessels and subsequent death of the patient.".
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