Catalog Number 1012448-12 |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/01/2016 |
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.
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Event Description
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It was reported that the nc trek balloon catheter was removed from the plastic hoop, the balloon was missing.There was no reported resistance during sheath removal.It appeared as if there was never a balloon attached to the catheter.The device was not used.There was no patient involvement.Another nc trek balloon catheter was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Correction - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded at the account.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported complaint.
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Manufacturer Narrative
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(b)(4).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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Search Alerts/Recalls
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