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: "the returned product was inspected in our r&d laboratory.By cutting the catheter at the level of the rupture, we discovered under the binocular microscope, a green compacted filament, which caused the occlusion.Due to the fact that there was no difficulty observed with the mandrel insertion during manufacturing, and also during the flushing of the catheter before the procedure, the above-mentioned filament could have been injected inside the catheter with the contrast liquid during the procedure.Furthermore, as mentioned in the ifu: the using pressure must not exceed the maximum value of 7 bars/100 psi as indicated on the label; the procedure must be stopped and the catheter removed immediately if any resistance occurs during the injection.All catheters of this batch number succeeded the 7 bars pressure test during manufacturing.As a result, to obtain the mentioned rupture, a pressure higher than 7 bars was reached (with a resistance in the syringe) during the procedure.No similar complaint was reported on this batch number.".
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