Int'l ((b)(6)) complaint received reporting "balloon broken" on one 52510-12 8fr optiq catheter.It was reported this occurred during pre-insertion testing where there was no pt involvement.Device return: one used 52510-12 8f catheter attached/to st-09880 contamination shield was returned for investigation.The "as-received" catheter showed residual blood was present on the returned devices.Visual inspection and analysis (pre and post decontamination) of the 52510-12 8f catheter recorded the catheter balloon was damaged/torn.Based on the visual inspection, the reported "broken balloon" issue was confirmed.Lot build review: a review of the mfr lot build database for the reported lot# 30-600-jw (mfg date 06/01/2013) shows 300 units were mfg, tested, inspected and released.There was no exception documents generated during the lot build.Add'l investigation: search/review of the #st-09880 contamination shield documented this device model is intended for use on 7/7.5 f catheters.
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