Catalog Number SGW-250-SD |
Device Problem
Kinked (1339)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The wire guide is kinked approximately 3.6 cm from the distal end.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.Prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.It is possible this occurred due to product handling conditions after release from cook inventory.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Event Description
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In preparation for a procedure, the user selected a cook savary-gilliard wire guide.After opening the package, they noticed that the tip of the wire guide was bent.There was no patient contact.
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Search Alerts/Recalls
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