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Model Number H74939207100870 |
Device Problems
Detachment Of Device Component (1104); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/13/2015 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: (b)(6).(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in a fistula in a left arm vessel.A 10.0 x80, 75cm gladiator balloon catheter was selected for use and advanced to post dilate a deployed non bsc stent.However, upon inflation, the balloon ruptured and the balloon ripped in half during withdrawal.The physician had to do a small cut down to retrieve the detached balloon segment.No patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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