Catalog Number SGC0301 |
Device Problems
Break (1069); Positioning Failure (1158)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Internal file number -(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
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Event Description
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This report is filed as a cable break occurred.It was reported that during steerable guide catheter (sgc) preparation, too much (b)(6) was applied and the cable broke.There was no sgc tip deflection noted following.The device was discarded and not used.There was no patient involvement.No additional information was provided regarding this device issue.
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Manufacturer Narrative
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Internal file number : (b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The investigation determined that the reported mechanical issue of unable to curve guide was a result of the cable break.The cable break appears to be related to the user technique.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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