Model Number LDC213T |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/24/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
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Event Description
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The physician's office reported an issue encountered with the lacrimal duct balloon catheter device during use.They reported the device would not inflate.The report stated this was observed during the procedure.As a result of the alleged event, the physician changed out devices and successfully completed the procedure.There were no patient complications reported as a result fo the alleged event.The device was returned to the manufacturer for evaluation.
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Manufacturer Narrative
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Visual inspection under magnification while using water-filled inflator identified a lead at the bonding site of the balloon to the catheter.Uv adhesive was not sufficiently added to that area.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
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Search Alerts/Recalls
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