Catalog Number 1012451-15 |
Device Problems
Inflation Problem (1310); Nonstandard Device (1420); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
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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).The device is expected to be returned for investigation.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].
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Event Description
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It was reported that the procedure was to treat a 95% stenosed, non-calcified lesion in the narrow mid right coronary artery (rca).When unpackaging a 3.5x15 nc trek rx balloon dilatation catheter (bdc), after flushing the lumen per the instructions for use, the protective sheath was difficult to remove; after several removal attempts and with strong force applied, the sheath was ultimately removed.The nc trek rx bdc was soaked, but air aspiration outside of the anatomy was not performed.The nc trek rx bdc was advanced to the lesion without resistance then air aspiration was performed.When attempting to inflate bdc, the balloon did not completely expand and contrast was noted under fluoroscopy to be exiting the balloon into the vessel; the balloon was reportedly broken.The bdc was withdrawn without resistance.The physician reported that the strong force required to remove the protective sheath may have caused the balloon to rupture.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was 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 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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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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