Catalog Number 1012452-12 |
Device Problems
Nonstandard Device (1420); Difficult to Remove (1528); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.On march 14, 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, [medwatch # 2024168-2017-02310].The abbott internal recall number is 2024168-3/14/2017-002-r.
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Event Description
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It was reported that the procedure was to treat a lesion in the heavily tortuous, heavily calcified mid circumflex (cx) coronary artery.A 3.75 x 12 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure.During preparation the protective sheath was difficult to remove from the balloon, but was able to be removed.The bdc was advanced to the lesion and was unable to cross due to the anatomy.The bdc was replaced with an unspecified device to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the device returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.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.Abbott vascular communicated the voluntary field action to the fda.Corrective action has been implemented per site operating procedures.The product will continue to be trended.
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Search Alerts/Recalls
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