Catalog Number 1012447-12 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Patient Involvement (2645)
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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.The device is expected to be returned for evaluation.It has not yet been received.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 during device preparation and prior to use the 2.5 x 12 mm nc trek balloon protective sheath met resistance and was difficult to remove.The device was not used; therefore, 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 was returned for analysis and abbott vascular (av) was able to confirm the reported difficulty removing the protective sheath.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the device performance with regards to the difficulty with removing the protective sheath appear to be related to normal variation found in manufacturing.There was no indication of a product quality issue.The performance of these devices will continue to be monitored.
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Search Alerts/Recalls
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