Catalog Number 1012450-12 |
Device Problems
Nonstandard Device (1420); Difficult to Remove (1528); Stretched (1601)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/22/2017 |
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 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 a 3.25 x 12 mm nc trek rx balloon dilatation catheter (bdc) was selected for the procedure.Resistance was felt while attempting to remove the protective sheath.They continued to pull on the protective sheath trying to remove it and the distal end of the shaft of the bdc stretched.The bdc was not used in the procedure.There was no patient involvement.There was no reported clinically significant delay in the procedure.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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