(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Incorrect prep.Evaluation summary: the device returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.On (b)(6) 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues.Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints.To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on (b)(6) 2017 [medwatch # 2024168-2017-02310].Corrective action has been implemented per site operating procedures.The product will continue to be trended.The abbott internal recall number is (b)(4).
|
It was reported that during preparation of the 3.5 x 12 mm nc trek balloon dilatation catheter (bdc), the bdc was prepped for use with the sheath on.After prep, several attempts were made to remove the sheath and stylet, but were unsuccessful.The device was not used in the anatomy and was replaced.A new 3.5 x 12 mm nc trek bdc was used without issue.There was no clinically significant delay in the procedure.No additional information was provided.
|