Catalog Number SGC0101 |
Device Problems
Leak/Splash (1354); Unstable (1667)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/29/2016 |
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 customer reported the steerable guiding catheter 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 for the leak, which if the device was used, has the potential to cause or contribute to serious injury.It was reported that during device preparation of the dilator, the cap of the hemostatic valve (rhv) was turned too tightly in the closed position causing the cap to fall off.Extension tubing was attached to the dilator rhv, but leaking was noted.This device was not used in the patient.Another dilator was used to complete the procedure without further incident.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the reported dilator cap detachment appears to be a result of user technique.The reported leak was likely a secondary effect of the cap detachment.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing or labeling of the device.
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Search Alerts/Recalls
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