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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.This complaint has been deemed mdr reportable under this program and recorded in the balt usa complaint management system on 21-09-2020.Balt usa's reference number: (b)(4).It was reported that, "the physician was treating an avm off of the left vert and had used magic to get into pica.The catheter had gone as distal as it could go and when doing contrast runs the catheter was hemorrhaging back into the basilar.This happened multiple times bending the pink pursil.We did many prior runs that were fine so i know that this was not punctured during prep or while entering the patient.We started to notice the contrast blush coming from the catheter in the basilar and thought the magic was perforated.We removed the catheter and saw that saline was coming out of the side of it in the pink pursil.No embolic was put thru the catheter and the patient was not harmed." here is the summary of event and investigation as reported by balt extrusion: pending device return.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report, or related information is an admission that the manufacturer, their employees, or the device caused, or contributed to the reportable event.
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Balt usa's reference number: (b)(4).This reported complaint concerns a balt extrusion device.As legal manufacturer, balt extrusion is responsible for the all post-market activities including the investigation, root cause, and customer follow-up related to this complaint.Balt usa commercializes a similar device in the us market which is also manufactured by balt extrusion, and has initiated this complaint for the sole purposes of evaluation for potential reportability under united states mdr requirements.Here is the summary of event and investigation as reported by the balt extrusion: the returned device was inspected in our quality department with the support of the engineering teams.During our analysis: we observed the magic under binocular and we confirmed a rupture with a "bubble" shape on the microcatheter distal extremity (white pursil) approximatively at 100mm from the distal part (see picture attached for illustration).Then, we checked the internal lumen of the microcatheter performing a longitudinal cut, but we did not notice any foreign matter (e.G.Fibers) which could have occluded the magic's lumen (see pictures attached for illustration).This configuration of rupture site with a tubing inflation and dilation is typical of an overpressure.We don't identified any damaged on the pink pursil despite of the incident description the review of the lot history records (lhrs) for this specific magic batch did not highlight any anomaly that could potentially explain the issue experienced during the procedure.During the manufacturing process, following tests are performed: integrity of the tubes is 100% controlled by visual inspection; smooth navigation of a gauge (0.25mm) through the microcatheter over the entire length is 100% controlled; all catheters are 100% controlled with a leakage/pressure test and 2 samplings are tested till bursting as destructive test.No other complaint is registered on this batch 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.By definition, internal lumen of the microcatheter was purged with saline during preparation and before injection of contrast liquid in the patient as described in the instructions for use: no leakage were noticed at this stage according to the issuer.Based on the observations made during the analysis and the data issued from our post-marketing surveillance program: these kinds of catheters ruptures (i.E.With a tube dilation) are generally explained by an overpressure above the maximum 7-bars limit as per indicated on the label and in the instructions for use.This overpressure could be explained by a too strong injection and an occlusion of the microcatheter magic.It could also be explained by the inadvertent injection of an impurity (e.G.Fiber) in the microcatheter's lumen during the flushing and/or the contrast liquid injection.As mentioned on the label and in the ifu (§ 6) "the using pressure must not exceed the maximum value of 7 bars/100 psi as indicated on the label.Do not infuse with a syringe smaller than 2,5 ml (piston diameter smaller than 10 mm).The procedure must be stopped and the microcatheter removed immediately if any resistance occurs during the injection".In conclusion, we lack information to accurately determine the origin of the reported event even if the quality of the device does not seem to be involved.The most probable cause could be an overpressure above the maximum limit allowed and so, could be linked to the device handling by the user.Comprehensive analysis of this failure mode will remain subject to continued tracking for any unacceptable increase in trend as part of our postmarketing surveillance program.At this time, no such increase has been observed.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
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