Product reference 4430000 is not cleared for sales in the usa, but its catheter is similar to the product reference 5436717 cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.Another similar complaint has been reported to us on this batch of access ports released in december 2015.Investigation results: we received for investigation a celsite access port nr 36903717 with the proximal part of the catheter.This segment measures 4.2 cm.At the level of the rupture, the catheter presents marks of pinch or kink.Dimensional measurements: we have measured the returned catheter in order to check its conformity to our specification.The internal and external diameters conform to our requirements.Conclusion: the catheter rupture is probably due to a kink or a pinch of the catheter.Only the examination of the x-ray pictures could confirm this hypothesis.The evaluation of the explanted device did not allow us to detect any manufacturing defect on the device.The ifu specifies to ensure there is no kinking of the catheter during the implantation procedure.The risk of catheter rupture is a known complication of the access port implantation.The complaint rate is low (<0,01%).No manufacturing defect has been detected on the returned sample.Consequently, no corrective action is envisaged.
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