Model Number H74939186202210 |
Device Problems
Entrapment of Device (1212); Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that the catheter froze on the wire.The target lesion was located in the posterior tibial artery.After a.014 non-bsc guide wire crossed the lesion, a 2.5x120 coyote balloon catheter was advanced for dilation.Upon removal, it took some effort to get the balloon off the wire.The device eventually released from the wire, wire position was maintained and the procedure was completed with a non bsc balloon catheter.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that the balloon catheter was completely stuck with the guide wire and everything had to be removed.While outside the patient, there was still difficulty in removing the wire.
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Manufacturer Narrative
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Upn- search corrected from unk719 - coyote - cmc - maple grove (peripheral interv) - 35000 to h74939186202210 - coyote, 2.0mm x 220mm x 150cm, otw - 39186-20221.Upn corrected from unk719 to h74939186202210.Catalog/model # updated.(b)(4).
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Event Description
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It was further reported that the balloon catheter was completely stuck with the guide wire and everything had to be removed.While outside the patient, there was still difficulty in removing the wire.
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Search Alerts/Recalls
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