Catalog Number M0032072409150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)
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Event Date 07/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available to the manufacturer.
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Event Description
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It was reported that angioplasty was performed to treat a 70% basilar tip stenosis using two balloon catheters.The first balloon (subject device) was unable to be inflated.Then the second balloon was used and was unable to be inflated as well.After usage of the second balloon, the patient experienced a subarachnoid hemorrhage (sah) and the procedure was stopped.The patient did not wake up for a long time after the procedure and after the patient woke up, it was found that he had a stroke with one sided hemiplegia.No further details were provided.
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Manufacturer Narrative
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The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.Patient hemorrhage, blood loss, patient stroke and one sided hemiplegia (paralysis) are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu); therefore, anticipated in nature.However, because the device was not returned the exact cause for the difficulties encountered with the device cannot be definitively determined.
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Event Description
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It was reported that angioplasty was performed to treat a 70% basilar tip stenosis using two balloon catheters.The first balloon (subject device) was unable to be inflated.Then the second balloon was used and was unable to be inflated as well.After usage of the second balloon, the patient experienced a subarachnoid hemorrhage (sah) and the procedure was stopped.The patient did not wake up for a long time after the procedure and after the patient woke up, it was found that he had a stroke with one sided hemiplegia.No further details were provided.
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Search Alerts/Recalls
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