This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.The complaint received states that during use ascent balloon catheter 4 mm x 7 cm (brs00040700 / unk) burst.¿busted by venting the balloon.¿ it was reported that the balloon burst during prep on the back table.There is no report of injury for the patient.No defects were found during the catheter outer body surface inspection except on the balloon area where a longitudinal tear of 13mm from the proximal seal and the distal seal was found.The length between the proximal seal and the distal seal was 13mm.This is an indication that the balloon was over inflated which resulted in stretching the balloon and possibly led to the rupture.100% leak testing is performed on each balloon catheter before it is released to determine whether the vent hole is open and whether or not the balloon leaks, so it is not likely that the balloon left micrus with a leak or rupture.The complaint was confirmed on analysis.100% inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the information suggests that procedural issues may have contributed to the confirmed event.
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