Model Number N/A |
Device Problem
Material Separation (1562)
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Patient Problem
No Code Available (3191)
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Event Date 12/11/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Event Description
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During a tulip filter removal, upon retracting the filter into the sheath with the retrieval device, the loop snare snapped off from the wire shaft inside the patient.The snare was retrieved using another retrieval device.A section of the device did not remain inside the patient铠body.According to the initial reporter, the patient did not require any additional procedures due nor experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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(b)(4).Event evaluation: a review of complaint history, device history record and specifications was conducted during the investigation.The device was returned with a separated handle.Also the black inner and the outer catheter were returned.Both catheters were kinked approximately 12cm from the distal end.No kink on the device.The device separation is in transition between the handle and the shaft most likely due to excessive forces used during the retrieval procedure.Under normal conditions the device is strong enough to accomplish the procedure.However, the device may break if exposed to stress caused by e.G.Twist or kink during the procedure.There is no evidence to suggest that device was not manufactured according to specifications.Per the instructions for use: excessive force should not be used to retrieve the filter.
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Event Description
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During a tulip filter removal, upon retracting the filter into the sheath with the retrieval device, the loop snare snapped off from the wire shaft inside the patient.The snare was retrieved using another retrieval device.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures due nor experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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