Catalog Number 1012452-08 |
Device Problems
Detachment Of Device Component (1104); Nonstandard Device (1420)
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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 is expected to be returned for evaluation.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].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 nc trek 3.75 x 8 mm was intended to pre-dilate the lesion.After the pouch was opened, the plastic hoop/coil was removed and then the protective sheath was removed with no resistance.When the balloon was going to be used to advance over the guide wire, the balloon was found to be missing.A new nc trek 3.75 x 8 mm was used instead which finished the procedure.No resistance was felt during the process.No other device issues or procedure issues were noted.The patient's final outcome is satisfactory with no patient effects.No clinically significant delay in the procedure was reported.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Internal file number - (b)(4).Evaluation summary: the device returned for analysis.The complaint investigation determined the issue was determined to be 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 (b)(6) 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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