Catalog Number 1012452-12 |
Device Problems
Kinked (1339); Nonstandard Device (1420); Stretched (1601); Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was received.Investigation is not yet complete.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 narrow and 99% stenosed mid left anterior descending artery (lad).An unspecified stent was implanted in the lad and a 3.75 x 12 mm nc trek balloon catheter was used for post-dilatation.There was resistance advancing the device due to the anatomy and when removed from the anatomy it was noted that the hypotube was bent.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.Returned device analysis confirmed the outer member was stretched at the proximal balloon seal.
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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, thus abbott vascular communicated the voluntary field action to the fda on march 17, 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 2024168-3/14/2017-002-r.
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Search Alerts/Recalls
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