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Model Number H74939207080470 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Code Available (3191)
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Event Date 11/18/2015 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: around 30s.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 occurred.The target lesion was located in a fistula in the left upper arm vessel.An 8.0mmx40mm, 75cm gladiator¿ balloon catheter was selected for use and advanced for dilation.However, upon inflation below the rated burst pressure, the balloon ruptured in a circumferential pattern.The physician was not able to retrieve the balloon back out through the sheath and the physician had to do a cut down to the artery into the fistula to completely remove the balloon.The patient did loose some blood but the physician was able to "stitch" the artery.The procedure was not completed.No further patient complications were reported and the patient's status was fine.
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Search Alerts/Recalls
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