The patient was referred for angioplasty for vasospasm mechanics.Chose to use a balloon catheter ascent 4x15 (brc00041500/f61117); the rupture of the material was observed during preparation.Followed the guidelines of preparation; according to the manufacturer and under the supervision of qualified representative of materials.A new balloon catheter (details unknown) was used and no complications in their preparation.We are sending the material back to the manufacturer for the analysis.The length between the proximal seal and distal seal was almost 20 mm which means the balloon was over stretched and as a result the unit was damaged.Prior investigations revealed that one of the possible failures when the balloon is over inflated is the occurrence of leaks which, with additional pressure on the balloon, may lead to longitudinal tears.Therefore, the root cause appears to be balloon over inflation.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 a rupture.Based on the information and the analysis, the event was confirmed.Additionally, review of this lot was performed and no outstanding discrepancies, design, or quality concerns were found.Therefore, no corrective actions will be taken at this time.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.
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