Device Problems
Inflation Problem (1310); Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601); Folded (2630)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/28/2016 |
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.Date of event - estimate.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the nc trek balloons have a slow inflation time, poor re-wrap, difficulty to remove the protective sheath, and stretched distal shaft.Additionally, it was reported that the profile on some balloons is high causing difficulty during removal through a 6 fr guiding catheter.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The udi# is unknown because the part number and lot number were not provided.The device was not returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.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.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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Event Description
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Additional information: it was reported that when using two balloons in a kissing balloon technique the profile on some balloons is high causing difficulty during advancement and removal through a 6 fr guiding catheter.No additional information was provided.
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Search Alerts/Recalls
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