COOK, INC. GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number N/A |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/26/2015 |
Event Type
malfunction
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Event Description
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According to the initial reporter, the physician encountered a defect in a filter retrieval set where the hub completely separated from the blue guiding catheter.Unfortunately the lot number was not saved for the report.The staff states that a similar event occurred recently as well.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects nor experience any additional procedures due to this occurence.Additional information has been requested, however, it was not provided at the time of this report.
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Manufacturer Narrative
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Lot # is unknown as not provided.Exp.Date unknown as no lot # was provided.Udi # is unknown as not lot # was provided.(b)(4).Investigation: a review of the complaint history, manufacturing instructions (mi), instructions for use (ifu), quality control (qc) and a visual inspection of the complaint device was conducted for the purpose of this investigation.The blue sheath with black inner catheter returned together with the long dilator.The hub has separated from the blue sheath.According to the manufacturing instructions, the sheath flaring must be 6.5 - 7.2mm.This flare is out of shape, but found to be bigger than 6.3mm and smaller than 6.75.However, since pulling the hub from the sheath will affect the shape and the flaring dimensions, the sheath flaring is found manufactured according to spec and consequently it is assumed that manipulation/pulling beyond its intended design caused the hub to separate.The ifu states: "excessive force should not be used to retrieve the filter." the investigation found the device was manufactured according to specifications, but strongly pulling during filter retrieval may have caused the hub to separate from the sheath.No remedial action is required at this time.We will continue to monitor for similar events.
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Event Description
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According to the initial reporter, the physician encountered a defect in a filter retrieval set where the hub completely separated from the blue guiding catheter.Unfortunately the lot number was not saved for the report.The staff states that a similar event occurred recently as well.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects nor experience any additional procedures due to this occurrence.Additional information has been requested, however it was not provided at the time of this report.
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